To evaluate respiratory and peripheral muscle strength after cardiac surgery.Additionally, we compared the changes in these variables on the third andsixth postoperative days.Forty-six patients were recruited, including 17 women and 29 men, with a meanage of 60.50 years (SD = 9.20). Myocardial revascularization surgery wasperformed in 36 patients, replacement of the aortic valve in 5 patients, andreplacement of the mitral valve in 5 patients.A significant reduction in respiratory and peripheral muscle strength and asignificant increase in pain intensity were observed on the third and sixthpostoperative days (p < 0.05), except for the variable maximalinspiratory pressure; on the sixth postoperative day, maximal inspiratorypressure values were already similar to the preoperative and predictedvalues (p > 0.05). There was an association between peripheral musclestrength, specifically between maximal expiratory pressure preoperatively, on the third postoperative day  and on the sixth postoperative day . Theeffect sizes were consistently moderate-to-large for respiratory musclestrength, the Medical Research Council scale and the visual analog scale, inparticular between preoperative assessment and the sixth postoperativeday.There is a decrease in respiratory and peripheral muscle strength aftercardiac surgery. In addition, maximal expiratory pressure is the variablethat is most associated with peripheral muscle strength. These variables,especially respiratory and peripheral muscle strength, should be consideredby professionals working in the intensive care setting. Inaddition, decreased preoperative RMS has been shown to prolong mechanicalventilation in the postoperative (PO) period and is described as a determinant ofdecreased functional capacity. Respiratory repercussions also generate changes inRMS, as well as changes in lung volumes and capacities, alveolar dysfunction,depression of central respiratory stimulation, and mechanical disorders of thoracicfunction.,4,11 In addition, it is known that most cardiac surgerypatients present with episodes of muscle weakness in the preoperative period, whichis accentuated after the surgical procedure. However, this muscle weakness is morenoticeable in the respiratory muscles than in the peripheral muscles, although thelatter muscles are also inactive.,13In cardiac surgery patients, decreased RMS has been associated with decreasedfunctional capacity and has contributed to a prolonged period of recovery of lungfunction and the occurrence of physical deconditioning, which can last for severalweeks.,15Another important factor in this context is the role of postoperative pain in thefunctional recovery of the patient, which is an important indicator to estimate thephysical and psychological tolls because prolonged painful stimuli cause sufferingand complications in the PO period, which correlate with increased morbidity andmortality by affecting the ability to cough, breathe, and moveproperly.In view of the above, the objectives of this study were to evaluate RMS andperipheral muscle strength (PMS) after cardiac surgery and to analyze the changes inthese variables on the third and sixth PO days, observing possible alterations inmaximal respiratory pressures and possible correlations with PMS and pain.Centro Universitário Tiradentes (protocol number40004314.6.0000.5641). The nonprobabilistic convenience sample was composed ofpatients in the pre- and PO periods for cardiac surgery who were admitted toHospital do Coração of Alagoas . In compliance with Brazilian and international ethical standards,patients were informed about the procedures to be performed and signed an informedconsent form to participate in this study.This was a longitudinal observational study. The data collection was carried out fromMarch to October 2016 after approval of the project by the Research Ethics Committeeof the Patients admitted to the hospital, both men and women over 18 years of age, underwentMRS and midsternotomy for valvular changes. Of these, patients who were cognitivelyimpaired were excluded from the assessment of RMS, PMS, and pain intensity. Patientswho had hospitalization-related complications that prevented their reevaluation werealso excluded.The evaluations were carried out at three time points. In the preoperative period (onthe day before cardiac surgery), an evaluation form with identification, disease,treatment, and anthropometric data was used; RMS, PMS, and pain intensity weremeasured.On the third and sixth PO day, the same evaluations performed in the preoperativeperiod were performed again by the same evaluator as shown in the 2O. Respiratory muscle strengthtests were performed with patients seated, lower limbs hanging, and feet supported.The nostrils were occluded with a nasal clip and the mouthpiece of the equipment wascoupled to the mouth. To evaluate the maximal expiratory pressure(EPmax), the patient took a deep inspiration to total lung capacity(TLC), during which the occlusion of the buccal orifice was performed, followed by amaximal expiration until the residual volume was sustained for at least 2 seconds.To assess maximal inspiratory pressure (IPmax), an expiration to residualvolume was taken, followed by occlusion of the orifice and maximal inspiration toTLC; the patient then maintained sustained strength for at least 2 seconds. Bothmaneuvers were repeated three times with a one-minute interval, and the best measurewas recorded for statistical analysis. Differences of 10% or less between valueswere accepted for each repetition. For the calculation of the predicted pressures,the equations proposed by Neder et al. were used.For the evaluation of RMS, the analog manovacuometer M120 was used, with a scale of ± 120cmH Measurements were repeated three times, with aone-minute interval, and the best measure was recorded for statistical analysis.For the measurement of PMS, the Medical Research Council (MRC) scale was used. Thisis a commonly used scale that is easy to execute and is low-cost. The individualsremained seated in a chair with the hip joint at 90º of flexion, the knee at 60º offlexion, and the trunk erect. The MRC test measures muscle strength capable of jointdisplacement against manual resistance applied by the evaluator during the followingjoint movements: shoulder abduction, elbow flexion, wrist extension, hip flexion,knee extension, and ankle dorsiflexion. When the scores for each evaluated movementare summed, the final MRC score ranges from 0 (tetraplegia) to 60 ; patients with scores lower than 48 are considered to have muscleweakness.Pain intensity was obtained by the visual analog scale (VAS), which consists of ahorizontal line 10cm in length that shows a range of pain levels from absence ofpain to the most intense pain and  were used.The data were entered into and stored in a database created in Microsoft Excel2010 software . Continuous variables were presented as themean and standard deviation; categorical variables were presented as relativeand absolute frequencies. Normality was tested using the Shapiro-Wilk test.Changes over time in respiratory and peripheral muscle forces were comparedusing the Kruskal-Wallis test. Correlations were evaluated using the Spearmancorrelation coefficient. An alpha value of 5% was adopted, and the StatisticalPackage for Social Science (SPSS) version 20.0  andBioStat and Fernández-Lao etal.: less than 0.20, negligible effect; 0.20 to0.50, small effect; 0.50 to 0.80, moderate effect; and > 0.80, largeeffect.Cohen's d was used to determine the clinical effect size of the proposedphysiotherapeutic interventions, with the interpretation based on theclassification established by Cohen2 (SD= 4.40) were included. Thirty-six (78.26%) patients had systemic arterialhypertension, and 21 (45.65%) had type 2 diabetes mellitus, whereas 22 (47.83%)patients never smoked, 14 (30.43%) had not smoked for at least 6 months, and 10(21.74%) were smokers.Forty-six patients were enrolled and evaluated in the study, with no losses. Thus, 17(36.96%) women and 29 men (63.04%) with a mean age of 60.50 years (standarddeviation [SD] = 9.20) and a mean body mass index (BMI) of 26.60kg/mRegarding the surgeries, MRS was performed in 36 (78.26%) patients, replacement ofthe aortic valve in 5 (10.87%) patients, and replacement of the mitral valve in 5(10.87%) patients. Of these, 41 (89.13%) surgeries were performed withextracorporeal circulation, with a mean time of 69.10 minutes (SD = 38.70). The meanlength of hospital stay was 7.10 days (SD = 2.1) . Regardimax, which onthe sixth PO day already had values similar to the presurgical value and predicted(p > 0.05).As shown in Curiously, there was a positive association between EPmax and PMS at different timepoints. Pain intensity was not correlated with RMS or PMS. Further details aredescribed in The main results of the present study were as follows: (1) EPmax was reduced at alltime points compared to predicted, whereas IPmax returned to preoperative values onthe sixth PO day; (2) PMS was reduced after the surgery; (3) postoperative painintensity increased through at least the sixth PO day; (4) RMS was directly relatedto PMS; and (5) RMS was not correlated with postoperative pain intensity.,22Although certain patient- and cardiac surgery-related risk factors are notmodifiable, knowledge of these factors is important for the health team, allowingthem to focus increased attention on the patients at greater risk to preventcomplications, morbidity, and death. concluded that after coronary artery bypassgrafting surgery, there was a major reduction in pulmonary function, which theauthor attributed to changes in circulatory factors that affect the synthesis ofmuscle proteins. In contrast, Urell et al. observed that RMS was not reduced at twomonths after cardiac surgery. However, the authors did not evaluate patients in theimmediate postoperative period; this may be particularly relevant because pain wouldhave needed to be considered.In the present study, there was a significant decrease in RMS seen on the third POday; however, it had returned at the sixth PO day. Corroborating in part the resultsof the current study, Roncada et al.observed improvement in both IPmax and EPmax 14 days aftersurgical procedures associated with the use of the device. While IPmaxrefers mainly to the force of the diaphragm, EPmax mainly reflects thestrength of the abdominal and intercostal muscles. In the present study,the reduction in IPmax was less than the reduction in EPmax.This could be explained by the fact that peak postoperative diaphragmaticdysfunction (decreased IPmax) occurs between two and eight hours aftersurgery, whereas the muscles associated with EPmax suffer greater damagefrom incision and surgical manipulation.In an evaluation of the clinical efficacy and feasibility of a respiratory musculartraining device applied to patients after cardiothoracic surgery, Crisafulli etal., Faustini Pereira et al. and Santos etal.reported that the loss of RMS was related to the decline in PMS, corroborating theresults of the present study, which demonstrated a positive and significantcorrelation between EPmax and PMS evaluated by MRC both in the preoperative periodand at both POD time points, that is, the third and sixth PO day. Santos etal.,Saglam et al., Faustini Pereira et al., also reported thatperipheral muscle strength showed an initial postsurgical loss with partial recoveryduring the PO period. This result is inconsistent with the results of the presentstudy. However, it should be noted that the postsurgical limitations may last for aperiod of six weeks to six months. In addition, it is already shown in theliterature that worsening of RMS and PMS, as well as cognitive and motor disorders,can be caused by neuromuscular lesions from factors such as mechanicalventilation,,30 anesthesia, extracorporeal circulationtime, medicines, malnutrition, and bed immobility.Additionally, a study conducted by Santos et al., which evaluated the PMS ofpatients undergoing elective cardiac surgery, concluded that PMS values wereremarkably reduced after surgery and returned to near baseline by the time ofdischarge, corroborating the results of the present study.Saglam et al.,33,34 Such protocolshighlight the importance physiotherapeutic intervention, which facilitates importantgains in both RMS and PMS and is a viable and safe strategy that preventscomplications, reduces the deleterious effects of immobility, preserves musclestrength, and thus results in higher functional performance.,35,36In recent years, protocols for the early withdrawal of sedation and for earlymobilization have been used in several intensive centers. In the current study, there was no correlationbetween VAS and RMS. The study of Sasseron et al., which aimed toevaluate the intensity and location of pain during hospitalization and its effectson the RMS of cardiac surgery patients, showed a correlation between pain in thefirst PO day and the decrease in the IPmax. Decreased PMS in individualswith heart disease has been reported in the literature. In addition, peripheralmuscle weakness is associated with reduced muscle strength and loss of physicalfunction.39 Another studywith the objective of evaluating the interaction between handgrip strength (HGS) andmyocardial oxygen consumption index (MVO2) before and after cardiacsurgery showed that hand grip strength had different effects on MVO2prior to and after myocardial revascularization; HGS might be used as a predictor toassess oxygen consumption in cardiac patients.The decrease in RMS and PMS in the postoperative period seems to maintain a directrelationship with pain. who observed increased pain until the fourth POday. Pain intensity was considered tolerable (VAS between 2 and 3). Similarly, inprevious studies,,42 patients most frequently mentioned the surgicalincision in the sternal region as the site of pain.In our study, there was a significant increase in pain on the third PO day, withmaintenance of the pain intensity until the sixth PO day, corroborating the findingsof Andrade et al.Interestingly, although pain evaluated by the VAS did not show a significantdifference, a moderate to high clinical difference was observed over the third andsixth PO day. Pain could have been a limiting factor for RMS; however, that was notobserved in this study. Corroborating our study, Urell et al. showed that RMS wasnot impaired, neither before nor two months after cardiacsurgery.The findings indicate that evaluation and monitoring of RMS and PMS is indispensableand assists in the analysis of severity, assessment of functional implications, anddetermination of the risks of pulmonary and neuromuscular dysfunction, thusproviding information supporting the need for adequate muscular training to improvethe strength of the respiratory and peripheral muscles and thus improving functionalcapacity.The present study has some limitations. First, the number of patients was relativelysmall. Second, there is no gold standard for the assessment of PMS; however,dynamometry has been demonstrated in the literature to be an effective, practicaland reproducible method. In this respect, we affirm that all measures were carriedout by strictly following the guidelines to ensure the adequacy and standardizationof the test procedures. Finally, we understand that limiting upper limb movementsmay have biased MRC responses, although the assessment of peripheral muscle strengthwas tested in small ranges of motion.We conclude that there is a decrease in respiratory and peripheral muscle strengthassociated with cardiac surgery. In addition, maximal expiratory pressure is thevariable that is most associated with peripheral muscle strength. Thus, to improveboth respiratory and peripheral muscle strength, professionals working in intensivecare settings should consider these variables in relation to preoperative andpostoperative interventions.


Neural Therapy (NT) is a common complementary treatment approach using injections with short-acting local anesthetics to treat pain and chronic diseases. However, little is known about the underlying mechanisms and the domains of treatment response. This study therefore analyzed patient experiences following NT injections with procaine.Maximum variation sampling was used to collect data from semi-structured interviews conducted with 22 hospital inpatients aged 59.6 ± 14.9 years . Each had multiple (9.4 ± 6.9) diagnoses. They were undergoing two weeks of integrative treatment, which included individualized NT. The interview data were analyzed in MAXQDA using qualitative content analysis.With injection, patients first described local anesthetic effects including temporary blocking of pain and increased local warmth. Second, patients reported on vegetative reactions frequently leading to turmoil within the body like initial aggravation of existing symptoms or the appearance of new, concealed or phantom symptoms. This often required the need for rest to deal with the treatment stimulus. As a third step, many patients could gain physical and emotional release and relief in symptoms, mood and functioning. Emotional release was often accompanied by weeping and initially overwhelmed affected patients with dissociated memories. However, in cases where patients were able to experience those memories with a new distance, a fourth step of integration was achievable. It included reframing processes as well as a gain in pain perception and body-awareness. As a possible fifth step, patients experienced improved mood, increased pain acceptance and empowerment. Adverse events of NT included pain from the injections, vegetative complaints and emotional turmoil that lasted for minutes or hours, with a maximum of two days.Patients treated with procaine injections reported different psychophysiological outcomes contributing to the understanding of the mechanisms underlying NT. Further efficacy studies should separate specific NT from non-specific/placebo effects.DRKS00004567.The online version of this article (10.1186/s12906-018-2369-4) contains supplementary material, which is available to authorized users. Neural Therapy (NT) uses injections of short-acting local anesthetics (mainly procaine) for diagnosis and treatment of chronic pain conditions and functional diseases . AccordiResearch into NT is limited. A 2005 Health Technology Assessment revealed evidence from case series and retrospective cohort data showing symptom improvement in up to 80% of 3812 treated patients, and preliminary data on cost-effectiveness in ambulatory care . FurtherThis study was conducted in accordance with the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines .The study was designed as a single center, qualitative interview study with post-intervention assessment. Prior to patient recruitment, the research protocol was approved by the Ethics Committee of the University of Duisburg-Essen, Germany (12–5208-BO), and registered at the WHO International Clinical Trials Registry Platform/German Clinical Trials Register (DRKS00004567). The study was conducted between November 2012 and November 2014 at the Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen, Essen, Germany.Maximum variation sampling was used  to generDuring the two-week inpatient stay, patients received individualized integrative treatment including conventional as well as complementary therapies . If indiThe researchers used semi-structured interviews to collect the study data. The interview guide developed by the research group  was piloted with three patients receiving the described study treatment. The guide’s final version included both general and more detailed questions about the patients’ treatment expectations, their physical and psychological responses to the NT, the effects on quality of life, and treatment safety  using MAXQDA software . The resulting codes were summarized to minor and major themes and paraphrased by an interdisciplinary group consisting of a physician (FJS), two medical students , two psychologists , and a cultural scientist (BB) using inductive qualitative content analysis techniques . RespectThe final study sample consisted of 22 inpatients  aged 59.6 ± 14.9 years. No patient refused to participate or withdrew consent for any reason. Most patients had multiple morbidities, with an average of 9.4 ± 6.9 diagnoses each. The main conditions for which they were receiving treatment included polyarthritis, osteoarthritis, spondylosis, radiculitis, fibromyalgia, chronic neck pain, tension headaches and migraine, irritable bowel syndrome, sinusitis, fatigue, recurrent depressive episodes and pain after surgery for metastatic breast cancer. During their inpatient stay, patients received on average 1.32 ± 0.95 NT treatments. Individual treatment characteristics can be found in the Additional file The qualitative data analysis process, described above, generated 278 codes, grouped hierarchically under 5 major and 19 minor themes (Table - “I considered this as a chance. I thought: What do I have to lose? I have nothing to lose.” (13|58)- “I was really worried. I don’t want to leave this hospital in a wheelchair, I told the doctor. But he reassured me and I’m very thankful that I could ask all of my questions.” (10|62)Patients reported hope of improvement as well as attitudes of ‘wait and see’ and ‘nothing to lose’. Several patients also emphasize fears about injections and possible treatment side effects.- “You need trust. I would not allow anyone to use such long needles on such sensitive body parts.” (20|93)- “The safe environment here, which I did not have outside, to allow yourself to fall.” (05|110)Patients stated a trustful relation to the doctor as most important to feel safe and engage in the invasive NT treatment.- “Well, you feel a little prick and later on a diffuse feeling of pressure.” (10|44)- “My pain was suddenly blown away. […] And it became warm, right up to the knee. And the next time, right up to the foot.” (16|43–46)Following the injections, patients described a number of local anesthetic effects, including the disappearance of pain, sensations of diffuse pressure and improved circulation adjacent the treated vessels.- “I got a little dizzy at first, but only for a short while, then I felt warmth spreading out into my feet. A very comfortable feeling.” (14|42)- “This was such an exhilarating feeling. There was nothing: you felt nothing, you thought nothing, nothing at all.” (13|30)- “As if I was on a beautiful cloud. Such a calm, content and decelerated feeling. [...] I was very close to myself, very focused. The view goes deeply inwards. Similar to what happens when I practice Yoga.” - “During the injection, I noticed that my eyes were welling up and that my nose was running. That did not happen for the last 20 years! I was so happy at having a runny nose.” (07|47)- “I had to go to the toilet about five times that night, passing water.” (17|56)- “My periods started, which shouldn’t actually be possible, because I haven’t had any periods since I got my coil put in, two years ago.” (21|66)Patients frequently reported a range of vagotonic/sympathicolytic reactions following their NT. These included nausea and dizziness, as well as more pleasant feelings of relaxation, ease, inner peace and emptiness. Some patients noted that the latter reminded them of the altered states of consciousness that they have experienced during meditation. On a physical level, patients also described sensations of body warmth and surprising changes to their nasal secretion, urination and menstruation.- “Afterwards, I felt so tired but in a good mood because something was moving.”(03|55)- “I wanted to be alone. Walking through the park. That made me feel good.” (22|65)Some patients found their NT treatments exhausting, both physically and mentally, at times requesting additional time to deal with the treatment stimulus.- “My upper back has improved but the pain of my lower back has increased.” (19|91)- “And then, the teeth that I had had taken out started to hurt. [...] Isn’t that a sign that my whole body responded?!” In addition to the above, some patients found that the NT treatment led to a temporary aggravation of their existing symptoms or the appearance of new, concealed or phantom symptoms; the latter were usually seen as harmless systemic responses.- “At times, I had pain everywhere in my body. Every step hurt. And all of a sudden I can walk without any pain in my legs. So far, the pain has not returned. I am totally excited.” (21|64)- “I have had more solid bowel movements for two days now. This is a very rapid success, considering that I’ve had severe, debilitating diarrhea for nearly nine months.” (20|73)- “The next morning I thought: My hands - nothing hurts! I wasn’t sure; was that a dream? Was it real? How long would it last? Would it be gone by tomorrow? But it lasted until today. […] I still have pain in my back, although I’ve had two injections right here, but the tingling in my legs, the electrical ‘prickling’, is gone.” (13|34–38)Patients cited pain relief as the main effect of NT, alongside a softening of their scar tissue and a decrease in their muscle tension. Patients reported that most of their other conditions also improved post-treatment although, for some, this relief was brief.- “My foot was limp. You gave a try, you tried to move the foot, but nothing happened. And, at the moment that I had the injection, it felt as if life re-entered my foot.” (18|99)- “When the arthritis worsened, and got more painful, I felt as if my leg didn’t belong to me. Like a foreign object, a peg leg. And after the injection, my leg felt more vivid. It was mine. […] It’s great, growing back together again.” - “That supports me in listening even more to my gut feelings. [...] And I believe that I might be able to get much closer to my inner self, and trust more in what I really feel.” (20|67)Patients reported that their treatments had led them to regain sensitivity in parts of their bodies that had previously been impaired, describing the treated areas as generally more ‘vivid’. Their treatment also helped them to reintegrate parts of their bodies from which they had formerly felt alienated so that they felt more ‘whole’ again. These outcomes enhanced the patients’ bodily awareness, increasing their confidence in their personal feelings and intuitions.- “When you’ve got so many different places that hurt, you feel like you’re in a vice. As if my body was eighty years old. [...]. Now, I feel considerably younger!” (18|137)- “Afterwards, I felt as if I’d been in the fountain of youth [...]. And all the others said: Wow! You’re looking really great!” (03|63)- “Joy! Joy! […] I didn’t need my crutches anymore! I can’t believe it, after three and a half years!” (04|83)- “I’ve been discharged from medical rehabilitation, due to pain, and unable to work. Now, I have the courage to say, okay, I can imagine working for eight hours.” (13|50)Improving symptoms made patients feel notably younger. Many voiced excitement that their horizons have now broadened, in terms of their mobility and daily functioning; this occurred often after a long history of illness and suffering.- “Images flashed through my head, from right to left. I felt pretty confused.” (06|50)- “The injection made me think ‘I have to surrender’. I’ve had such a lump in my throat. […] And then, like a tornado, like a volcano, ‘I have to cry’. I’ve only ever seen pictures of my father. He died 49 years ago. I never said goodbye to him.” - “When I got the injection, it all spouted out of me. Suddenly, I saw images, memories resurfaced, I started to cry bitterly, I shivered. [...] I couldn’t control it at all. All those emotions came up to the surface again. I’m glad that it happened, because now it’s gone. It wasn’t threatening; in fact it was a relief.” Seven patients found that their injections triggered memories, overwhelming them with suppressed emotions. They reported recalling images at a high frame rate, experiencing them as uncontrollable and/or initially confusing; at times this was accompanied by shivering or nausea. All of these patients did not evaluate the release of emotions as frightening, but rather as a relief.- “And then I could allow that, tick, tick, tick, images from my memory popped up, like in a movie. I went through my entire tonsillectomy again. But this time, I saw the scene more as if from above. At the end, I felt that it was okay. […] That’s the way it happened. It wasn’t as frightening as the real surgery.” (01|52–54)- “Well, it was like a film running backwards. Like watching your life in reverse. [...] It was very realistic, or maybe not realistic, but like a critical view of something that you can’t change, anyway.” (03|135–137)Allowing post-treatment emotional release enabled many patients to see their personal memories from an increased distance, helping them to reevaluate and reintegrate their memories into new emotional contexts. This led patients to better acceptance and reconciliation of their personal history.- “I only knew that I had this deep sadness inside, which I couldn’t identify. I thought that I would’ve processed the miscarriage; that I could deal with it, but that wasn’t true. That wasn’t obvious to me. Not at all.” (21|34)The new associations that patients made between their memories and emotions led them to understand the context and function of their illnesses in greater depth.- “When I got the injection, suddenly, the images came back, everything that happened that day. All the feelings came back. […] And I cried, bitterly, until it stopped. And the next day, I felt such a release, as if a belt around my heart has split. […] I feel like I can breathe again, that the sadness is gone. With one treatment! And the pain in my hands has decreased. And the pain in my shoulders as well.” (21|28)Some patients linked their emotional release directly to improvements in their physical symptoms and body perception.- “The next morning I woke up and thought that something is different. Although the weather was actually cloudy, to me all the world seemed bright.” (11|27)- “I feel physically and mentally relieved. It’s really depressing having pain all the time, but you don’t want give up. You tackle the problem, but it’s always a struggle, a fight. And now, there’s less fighting and that’s great.” (06|120)Other patients did not report emotional release during their NT treatment, but found themselves feeling surprisingly happy and lighthearted, when it had finished. Reductions in their pain levels also led to a growing confidence and a new enjoyment of life after the lengthy periods that many had spent fighting against illness.- “Before the therapy, I cried a lot, because nothing seemed to work anymore. Now, I feel stronger, because the load is gone, this burdensome situation.” (19|77)- “I looked back carefully, once again, and decided to finish the whole thing off. It was so many years ago. This might be a new beginning for me.” (03|105)Some patients also reported on increased feelings of personal control over their everyday lives, increased engagement in active decision-making and greater feelings of empowerment and autonomy.- “The initial prick hurts and it continues to hurt until the needle has found its position. Then, the injection of the procaine causes a feeling of pressure. Sometimes I need to say ‘Stop - slower, please’, until the anesthesia occurs. Then it’s okay. That’s always a challenge.” (20|31)The main adverse event that patients experienced was pain at the time of their injections. They generally tolerated this because they expected the injections to improve their symptoms.- “And then I just felt sick. I thought I have to throw up. I felt dizzy.” (02|38)- “During the injection, I had hot flashes, which disappeared quickly. [...] Afterwards, I did feel quite exhausted, and sometimes a bit dazed, the closer the injections got to my head.”Other adverse events included vertigo, hot flashes, tiredness, headaches and exhaustion. Most of these outcomes were gone within minutes or hours, although some lasted for up to two days.- “I had nightmares, really bad nightmares. But they stopped as suddenly as they appeared.” (06|104)- “These memories appeared more frequently over the course of the next day and the next afternoon. They were quite intense.” (05|67)Some patients reported nightmares, the need to cry and/or the relive of previously traumatic events. These events unexpectedly faded away as quickly as they came.Most patients reported a temporary or sustained reduction in their symptoms, with many experiencing emotional relief and improved well-being. Three of the study patients said that NT had no effect on their pain intensity and two others that it did not affect their mood.- “Quality of life. Absolutely! Before the Neural Therapy, I managed my life alongside the pain. You took more pills, you took part, also laughed with other people, but you were strained all the time. Now my pain has got less, I’ve realized how relieved I am and how great it is.” (06|118)- “When the pain in my knee cartilage reappeared, I was very disappointed.” (16|107)- “[There was] no mood brightening, or anything like that. It was all quite normal.” (10|65)- “Here, Neural Therapy is embedded in a larger concept. This has led to more stability. Together with other tools that I use, I think, this has led to a more long-lasting effect.” (16|62)- “If I feel worse again, I would consider using Neural Therapy again.” (13|66)Patients attributed a range of local and systemic effects directly to their NT treatment. The integrative inpatient treatment setting also was perceived as supportive. Most patients reported that, based on their current experiences of NT, they would use it again.Patients treated with NT reported local anesthetic effects and systemic bodily responses resulting in the reduction of their pain and other symptoms, feelings of emotional release/relief and improvements in their general well-being in most cases. They perceived the treated areas generally as more vivid and better reintegrated into their body image. Improvements in daily functioning made patients feeling younger and enhanced their quality of life. NT injections also triggered states of altered consciousness, sometimes accompanied by the emergence of memories and the release of emotions. These processes of recall and release enabled patients to view their memories more from a perspective of a distant observer, helping them to reevaluate and reintegrate their memories into a new emotional context. This outcome led to emotional relief, cognitive reframing, pain reduction and a sense of empowerment. Other patients did not report distinct emotional events, but were surprised by post-treatment feelings of happiness, confidence and regained enjoyment of life. Adverse events included pain due to the injections, vegetative complaints and emotional turmoil that generally lasted for minutes or hours with a maximum of two days. In relation to the desired treatment effects, patients assessed these side effects as negligible.Temporary Block: Local anesthetics temporarily block pain transmission that patients perceive as the immediate disappearance of their pain ; this ofTurmoil: Besides interrupting the pain, NT appears to stimulate responses of the autonomic nervous system, frequently leading to turmoil within the body. Study patients described sensations of dizziness at this stage, and the need to rest in order to deal with the treatment stimulus. Their existing symptoms could be temporarily aggravated and new or phantom symptoms could occur. NT theory generally views such sensations as positive treatment responses. Reverse/reaction phenomena, for example, are defined as the worsening of treated symptoms shortly after segmental injection . Other c+-channels, procaine is known to modulate the inflammatory response and sympathetic nervous system activity by reducing the secretion of proinflammatory cytokines, inhibiting the signal transduction via G-protein coupled receptors and muscarinic m1/m3 receptors [Release and Relief: Subsequent to the experience of turmoil, which seemed to be a sufficient but not a necessary condition, patients could perceive physical and emotional release as well as relief in symptoms, mood and improved daily functioning. On a bio-physiological level, this link is explainable by the pharmacology of local anesthetics. Beside the reversible block of voltage-gated Naeceptors –32, and eceptors . This ineceptors . Researceceptors , 36 and eceptors  may alsoeceptors .Integration: Symptom relief can lead to consolidation and integration mechanisms, which may include improvements in pain perception and body/self-awareness  as well Empowerment: As a result of their NT treatments, the study patients reported that they felt empowered and better prepared to engage in a more active life.The above findings contribute to a deeper understanding of the mechanisms underpinning NT. They suggest that health improvement may be theorized as a process consisting of the following steps:This study has a number of potential limitations. Firstly, the inpatient setting might limit the generalizability of the findings. Although only quotes that referred clearly to NT were entered into the qualitative content analysis, it remains possible that study outcomes are not solely due to NT treatment but are due to combination with other inpatient treatments. Secondly, the study data were collected from participants during their inpatient stay. Thus, the data only reflect experiences and perceptions immediately after or a few days after their NT treatments. Questions about the possible persistence of any of the observed changes must therefore remain unanswered. Finally, it should be noted that conclusions drawn from qualitative data, even if maximum variation sampling was used, are neither representative nor reveal causal relations, as we could not control for placebo and non-specific treatment effects.Further studies should address the link between emotional release and physical relief phenomena. In addition, it should be investigated whether the observed effects are specific to NT in contrast to sham (efficacy research) or similar to other complementary or psychological treatment techniques (comparative effectiveness) . QualitaPatients treated with procaine injections reported different psychophysiological outcomes ranging from improvements in pain and chronic symptoms to enhanced daily functioning and mental quality of life. In cases where usual or local treatment approaches are not effective, expanded segmental and interference field techniques might offer a promising treatment option. Further quantitative trials should answer the question whether the observed effects are specific to NT or a consequence of unspecific mechanisms associated with the patients’ expectations, therapist attention, or other setting conditions.Additional file 1:Semi-structured interview guide. (DOCX 17 kb)Additional file 2:Individual NT treatments. (DOCX 19 kb)


Prehospital management of traumatic pain is commonly based on morphine while locoregional analgesia techniques, especially the femoral nerve block (FNB), can be safely and efficiently used. Adjuvants uses can reduce local anesthetic doses and decrease their related risk. The aim of the study was to assess the analgesic effect of magnesium sulfate when used as an adjuvant in prehospital FNB.  This is a randomized double-blinded trial conducted in a prehospital medical department of an academic hospital. Patients with isolated diaphysial femoral fracture and eligible to participate were randomized into 2 groups. Group C had a FNB with 15 ml of lidocaine with epinephrine (300 mg) and 3 ml of normal saline solution. Group I had a FNB with 15 ml of lidocaine with epinephrine (300 mg) and 3 ml of MgS 15% (450 mg). The FNB was performed according to the WINNIE technique. Primary endpoints were morphine consumption and pain intensity during the first 6 hours. Secondary endpoints were the duration of the sensory block, time to the first analgesic request, and side effects occurrence. p < 10−3), analgesic onset was significantly faster, and the average time to the first analgesic request was longer . The average duration of sensory block was longer in group I (226 ± 64 min versus 116 ± 70 min p < 10−3). No side effects were recorded.  Twenty-four patients were enrolled in each group. Both groups were comparable according to demographic characteristics, initial pain scores, and vital constants. In group I, morphine requirements were significantly lower . Magnesium sulfate should be considered as an efficient and safe adjuvant to lidocaine in prehospital FNB. This trial is registered with ( Traumatic pain is an independent risk factor of morbidity and mortality. It can lead to a decompensation of chronic diseases, a worsening of traumatic injuries, and an increase in blood loss through sympathetic activation. That is why, it is widely considered to be the fourth vital sign. Its management quality is one of the accreditation criteria of institutions in several countries.The prehospital therapeutic arsenal is based traditionally on morphine at the expense of neurological and respiratory side effects, which can already worsen a precarious condition related to traumatic lesions leading to a poor patient prognosis.Locoregional analgesia (LRA) techniques have been described to be safe and efficient in prehospital emergency medicine  especialN-methyl-D-aspartate (NMDA) receptors and its role in the regulation of calcium influx into the cell, magnesium sulfate (MgS) seems to have a potential analgesic effect when used as an adjuvant in FNB  versus a median of 3 mg and a IQI25%–95% of [3–9]; p < 10−3) (p < 10−3). The average duration of sensory block was higher in group I . No side effects were recorded during the study period.Morphine requirements were significantly lower in group I  . Analges < 10−3) . The aveIn this study, we found that the use of MgS as an additive to lidocaine in prehospital FNB for a patient with diaphysial femoral fracture improves analgesia quality. In fact, it reduces pain intensity with a rapid onset and a longer duration of time till the need for rescue analgesia. It also allows a reduction in morphine consumption without any side effects.To our knowledge, this is the first report of MgS use in FNB in prehospital settings. This should encourage the use of LRA, in this context, as a safe and efficient analgesic technique especially for traumatic pain. The FNB is particularly appropriate for prehospital LRA as it is easy to perform even without sonography or neurostimulation. Thereby, it can be performed worldwide, even in limited resources structures. In addition to a pain-free transportation, it can also prevent pain accentuation related to the initial hospital management such as medical examination, radiological investigations, and some orthopedic procedures , 4. ThusSeveral trials have evaluated analgesic effects of MgS. Its perioperative intravenous infusion leads to a significant decrease in anesthetic requirement and postoperative analgesics consumption –11. Postn=30) or FNB with bupivacaine and MgS (n=30). This study concluded that MgS adjunction provides a profound prolongation of block duration and a significant decrease in postoperative pain scores [In a randomized clinical trial, 60 patients undergoing laser photocoagulation for varicose veins of the lower limb were enrolled. Then, they were assessed to receive FNB with bupivacaine  receptors have a major role in central nociceptive transmission, modulation, and sensitization of acute pain states [Furthermore, Kashefi et al.  studied n states . Their an states . The mosn states , 22. Then states –12,19,20n states , 16.Magnesium sulfate should be considered as an efficient and safe adjuvant to local anesthetics in prehospital FNB. It allows a significant decrease in pain scores and opioid requirements without increase in adverse effects.


What is the benefit of a short hypnosis session before general anesthesia on postoperative outcomes  in patients who underwent minor breast cancer surgery?In this randomized clinical trial, 150 women were randomized to receive hypnosis or a control group, and the mean breast pain score before discharge was 1.75 in the control arm vs 2.63 in the hypnosis arm. At discharge, no statistically significant difference in breast pain was reported.No benefit of hypnosis was found on postoperative breast pain; however, hypnosis seems to have other benefits regarding fatigue, anxiety, and patient satisfaction. This randomized clinical trial compares the efficacy of preoperative hypnosis vs usual care for reducing postoperative breast pain in patients undergoing breast cancer tumor removal with or without limited axillary node dissection. Hypnosis is now widespread in medical practice and is emerging as an alternative technique for pain management and anxiety. However, its effects on postoperative outcomes remain unclear.To evaluate the efficacy of a preoperative hypnosis session for reducing postoperative breast pain in patients who underwent minor breast cancer surgery.The HYPNOSEIN prospective randomized clinical trial was conducted from October 7, 2014, to April 5, 2016. In this multicenter study in France, 150 women scheduled for minor breast cancer surgery were randomized between control and hypnosis arms, and 148 (71 control and 77 hypnosis) were included in the intent-to-treat analysis.On the day of surgery, eligible patients were randomly assigned (1:1) to the control arm or the hypnosis arm. Patients (but not the care teams) were blinded to the arm to which they were assigned. A 15-minute hypnosis session before general anesthesia in the operating room was performed in the hypnosis arm.The primary end point was breast pain reduction , assessed immediately before discharge from the postanesthesia care unit (PACU). Secondary end points were nausea/vomiting, fatigue, comfort/well-being, anxiety, and PACU length of stay, assessed at different times until postoperative day 30.P = .004). At PACU discharge and with longer follow-up, no statistically significant difference in breast pain was reported. Fatigue was significantly lower in the hypnosis arm on the evening of surgery . The median PACU length of stay was 60 minutes  in the control arm vs 46 minutes  in the hypnosis arm (P = .002). Exploratory analyses according to patient perception of whether she received hypnosis showed significantly lower fatigue scores in the perceived hypnosis subgroup on the evening of surgery . Anxiety was also significantly lower on the evening of surgery in the perceived hypnosis subgroup .The median patient age was 57 years  in the control arm and 53 years  in the hypnosis arm. Baseline characteristics were similar in the 2 arms. The median duration of the hypnosis session was 6 minutes . The use of intraoperative opioids and hypnotics was lower in the hypnosis arm. The mean (SD) breast pain score  was 1.75 (1.59) in the control arm vs 2.63 (1.62) in the hypnosis arm (The results of this study do not support a benefit of hypnosis on postoperative breast pain in women undergoing minor breast cancer surgery. However, other outcomes seem to be improved, which needs to be confirmed by further studies.EudraCT Identifier: 2014-A00681-46 and ClinicalTrials.gov Identifier: NCT03253159 In this “hostile” environment, most women undergo breast surgery, which can lead to even more stress.3 Studies5 have reported that within the first postoperative days patients experience moderate or severe pain (10%-20%), nausea/vomiting (10%-15%), drowsiness (10%), sore throat (15%), and hoarseness, causing anxiety and discomfort. Therefore, reduction of these postoperative complications remains a medical challenge, with economic issues that include delayed discharge from the postanesthesia care unit (PACU) and center, medical and pharmacological rescue, and readmission.Breast cancer is the most frequent cancer among women, with psychological, professional, and social effects.7 Nonpharmacological alternatives, including music, relaxation therapy, or medical hypnosis, have been shown to decrease perioperative anxiety, pain, medication requirement, and nausea/vomiting.11 Among them, hypnosis seems to be a convenient method, with advantages that include an inexpensive and simple technique with no specific adverse effects. Observational studies and meta-analyses have reported the benefit of hypnosis on postoperative pain and other postoperative adverse effects, anesthetic intake, and duration of stay in the PACU.14 In 2007, Montgomery et al12 showed that a brief hypnosis session (15 minutes) performed within 1 hour before breast surgery reduced both adverse effects and cost. Hypnosis has become popular in numerous hospitals, leading to enhanced empathy and verbal and nonverbal communication in the preoperative and intraoperative settings.14 However, these hypnosis techniques and attitudes have not been validated by rigorous randomized studies to date.Several strategies, such as premedication or pharmacological multimodal approaches, have been proposed to reduce these effects.The HYPNOSEIN prospective single-blind randomized clinical trial evaluated the effect of hypnosis performed immediately before general anesthesia on main adverse effects in patients scheduled for day-case breast cancer surgery. The primary objective of this multicenter study in France was to evaluate the efficacy of a preoperative hypnosis session for reducing postoperative breast pain in patients who underwent minor breast cancer surgery, assessed using a visual analog scale (VAS) in the PACU. We also investigated the effect of hypnosis on nausea/vomiting, fatigue, comfort/well-being, and anxiety.15 and the Good Clinical Practice requirements.16 All participants provided written informed consent before the study began. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The complete trial protocol is available in the This multicenter, prospective, randomized, single-blind, phase 3 clinical trial was conducted in the following centers: Montpellier Cancer Institute (ICM) and Montpellier University Hospital, Montpellier, France, and Paoli-Calmettes Institute, Marseille, France. The study was approved by the local institutional and ethics committee . It was conducted in accord with the ethical standards of the Declaration of HelsinkiPatients were included in the study if they were women older than 18 years with an indication for minor breast cancer surgery (cancer tumorectomy or tumorectomy with limited axillary node dissection). They had to be scheduled for day-case breast surgery , with general anesthesia. Patients were excluded if they had an American Society of Anesthesiologists score of 4 or higher, body mass index  less than 15 or greater than 45, or an indication for major surgery . Also excluded were patients who refused hypnosis or had undergone previous surgery with hypnosis and patients with psychiatric disorders, chronic pain, or the use of therapeutic opioids for more than 3 months.On the day of surgery, eligible patients were randomly assigned (1:1) to the control arm or the hypnosis arm. Patients (but not the care teams) were blinded to the arm to which they were assigned. To reduce bias (excessive empathy in the control arm), 2 different anesthesiologist teams were involved in patient care. Patients in the control arm were managed by caregivers without formal hypnosis training, and patients in the hypnosis arm were cared for by a dedicated team of staff trained in hypnosis.No premedication was given, and music therapy was not allowed. Patients in the control arm were prepared for surgery by the control team, with no specific recommendation on wording or nonverbal communication, and standard general anesthesia was used. In the hypnosis arm, patients were prepared for surgery by the hypnosis team, who started verbal and nonverbal communication immediately. A short individual hypnosis session (≤15 minutes) that was personalized to each patient was performed in all centers by a trained anesthesiologist who had been practicing the technique for more than 1 year. It was recommended that the anesthesiologist use sensorial language and paraverbal and rewording techniques to promote patient comfort/well-being according to her choice of a safe place or leisure activity. Family concerns and negative topics were avoided. During the hypnosis session, only the anesthesiologist talked with the patient. When the physician thought that the patient was ready for anesthesia, pharmacological anesthesia induction was performed in a manner similar to that for the control arm.cis-atracurium (0.3-0.5 mg/kg), if necessary. The airway was secured with an endotracheal or supraglottic tube, and the lungs were ventilated with a mix of oxygen and air (50%-50%). The tidal volume was set to 6 to 8 mL/kg of ideal body weight. Anesthesia was maintained using sevoflurane (1%-2%), and additional intravenous sufentanil citrate (5 μg) was administered during surgery if the heartbeat or systolic blood pressure increased more than 20%. During surgery, analgesics were administered, including acetaminophen (1 g), ketoprofen (50 mg), and ketamine hydrochloride (0.1-0.2 mg/kg). No local anesthetic solution was administered.Preoperative preparation, analgesia, surgery, and postoperative care were similar in the 2 arms in accord with the standards of the participating centers. Anesthesia induction was started intravenously with lidocaine hydrochloride (1 mg/kg), propofol (2-3 mg/kg), sufentanil citrate (0.1-0.2 μg/kg), and In the PACU, rescue analgesia (intravenous tramadol hydrochloride [50 mg]) was given to patients whose pain exceeded 3 on a 10-point numeric scale. If a score above 3 remained after 30 minutes, morphine sulfate titration (2 mg for body mass <60 kg and 3 mg for body mass ≥60 kg) at 5-minute intervals was administered until a score of 3 or lower was reached. In the first postoperative 48 hours, all patients received acetaminophen (1 g) and ketoprofen (50 mg) at 6-hour intervals by mouth.18 To treat nausea/vomiting after extubation, patients received intravenous ondansetron hydrochloride (4 mg). When necessary, oral ondansetron was administered during the first 48 hours after surgery (4 mg every 6 hours).As nausea/vomiting prophylaxis, all patients with an Apfel score exceeding 2 were given intravenous dexamethasone sodium phosphate (4 mg) and droperidol (1.25 mg) after anesthesia induction.The primary end point was breast pain reduction, assessed immediately before discharge from the PACU by 2 on the VAS. Secondary end points were evaluation on the VAS of the following: postsurgical nausea/vomiting, fatigue, comfort/well-being, anxiety, PACU length of stay, operative time, use and dose of antiemetics, analgesic consumption, and number of failed day-case surgical procedures. Outcomes were recorded using the VAS  by an independent clinical research associate before surgery, immediately before PACU discharge, at patient discharge on the evening of surgery, and at days 1, 7, and 30 after surgery. Assessments of outcomes in the PACU were performed by a blinded nurse. Patient satisfaction with care was evaluated the day after surgery on a scale of 0 to 10.19Randomization was stratified according to center. The sample size calculation was based on a difference of at least 2 on the VAS in the PACU between the 2 arms in terms of pain severity. To detect such a difference with σ of 3.5, 2-sided α risk of 5%, and power of 90% (β = .10), 66 patients per arm were required. Considering 10% of nonevaluable patients, a recruitment total of 150 patients (75 per arm) was planned.t test or Kruskal-Wallis test was used. Categorical variables were compared using χ2 test or Fisher exact test.All analyses were performed on an intent-to-treat basis according to the statistical analysis plan . No impuAn exploratory subgroup analysis was conducted to assess the effect of treatment group perception on end points. During their PACU stay, patients were asked whether they thought that they had received hypnosis (“Do you think you received hypnosis before anesthesia?”), and 2 subgroups (perceived hypnosis and no perceived hypnosis) were considered based on their perception. Accordingly, the pain, fatigue, comfort/well-being, and anxiety in each subgroup were described.P < .05 was considered statistically significant. Statistical analyses were performed using a software program .All tests were 2-sided, and Between October 7, 2014, and April 5, 2016, a total of 150 patients were randomized, and 73 and 77 were allocated to the control and hypnosis arms, respectively . Two patIn the hypnosis arm, the median duration of the hypnosis session was 6 minutes . The use of intraoperative opioids and hypnotics was lower in the hypnosis arm. After surgery, 25.0% (14 of 56) of patients in the control arm thought that they had received hypnosis, and 21.7% (15 of 69) of patients in the hypnosis arm thought that they had not received hypnosis.P = .01) for propofol and 19 μg  vs 15 μg  (P = .05) for sufentanil citrate. The proportion of patients who received lidocaine was lower in the control arm than in the hypnosis arm . The choice of airway management technique was also significantly different, favoring a noninvasive laryngeal mask in the hypnosis arm (70.1% [54 of 77]) vs in the control arm (53.5% [38 of 71]) (P = .04). The median PACU length of stay was 60 minutes  in the control arm vs 46 minutes  in the hypnosis arm (P = .002).Almost all patients (100% [71 of 71] in the control arm and 98.7% [76 of 77] in the hypnosis arm) underwent tumorectomy or quadrantectomy . The medP = .004), which prohibited interpretation of these results and analysis of the effect of hypnosis on PONV. One month after surgery, no serious adverse event or medical or surgical complication had been reported in either of the 2 arms.The postoperative nausea/vomiting (PONV) prophylaxis was different in the 2 arms: 47.9% (34 of 71) of patients received prophylaxis in the control arm vs 24.7% (19 of 77) in the hypnosis arm (P = .004), favoring the control arm  (The mean (SD) breast pain score , assessed immediately before PACU discharge, was 1.75 (1.59) in the control arm vs 2.63 (1.62) in the hypnosis arm (o −0.29) . At discP = .03). Levels of comfort/well-being and anxiety immediately after surgery were similar in the 2 arms. At days 1, 7, and 30 after surgery, there was a tendency toward lower levels of fatigue, comfort/well-being, and anxiety in the hypnosis arm compared with the control arm, but the differences were not statistically significant. The mean (SD) perioperative care patient satisfaction evaluated on the day after surgery was 8.9 (1.5) in the control arm vs 9.5 (1.1) in the hypnosis arm (P = .02) (The mean (SD) VAS scores for fatigue in the PACU were 3.81 (2.56) in the control arm vs 3.66 (2.40) in the hypnosis arm, which was not significantly different  . The meaP = .02) .P = .01) and on day 1 after surgery  (P = .03). At days 1, 7, and 30 after surgery, levels of fatigue, comfort/well-being, and anxiety were not statistically different in the 2 treatment perception subgroups.Exploratory analyses were conducted according to patient perception of whether she received hypnosis. Patient characteristics were well balanced for the 2 subgroups of perceived hypnosis (68 of 125 patients [54.4%]) and no perceived hypnosis (57 of 125 patients [45.6%]). Significantly lower fatigue scores were reported in the perceived hypnosis subgroup on the evening of surgery   . The levWe report the results of a multicenter, prospective, randomized, single-blind phase 3 clinical trial evaluating the benefit of preoperative hypnosis sessions in day-case minor breast cancer surgery. There was no benefit of a hypnosis session performed immediately before general anesthesia induction on postoperative breast pain in these patients. However, patients who thought that they had received hypnosis had significantly lower postoperative fatigue and anxiety.14 showed that suggestive or hypnosis techniques reduced anxiety but did not significantly affect postoperative analgesic consumption. Furthermore, in the present study, an observed difference in breast pain was significant in the PACU in favor of the control arm but was not found for later time points.Although breast pain was scored significantly higher by the patients in the hypnosis arm, this difference in pain level did not result at the clinical level in a higher consumption of ketamine and morphine in the PACU for these patients. Indeed, patients had similar need for rescue analgesia and pain relief in the PACU in the 2 arms. A 2014 meta-analysis by Kekecs et alP = .002). Also, fewer patients received lidocaine in the control arm than in the hypnosis arm. This may have affected postoperative pain perception, together with the fact that more patients received PONV prophylaxis in the control arm, which may have resulted in less pain compared with the hypnosis arm. Second, the choice of surgery may also explain our results. Patients underwent minor breast cancer surgery, an intervention that induced limited postoperative pain because of a minimally invasive surgical technique (tumorectomy). We used a multimodal analgesic strategy , which is the standard of care for pain control in these patients. In both study arms, patients received intravenous acetaminophen, ketoprofen, and ketamine. This strategy enabled effective pain relief by our teams for all patients. Indeed, patients in the control arm reported a low median pain intensity in the PACU . Reducing pain even further with hypnosis may have been an unreasonable goal because of these low pain levels.There may be 2 reasons for our results herein. First, patients in the hypnosis arm received lower doses of the intraoperative anesthetic drugs propofol and sufentanil, which may explain the lower pain levels in the control arm. This may be linked to the statistically significant reduced PACU length of stay for patients in the hypnosis arm . In that study, data were not available on pain reduction in the days after surgery.The randomized clinical trial by Montgomery et alP = .04). This suggests that hypnosis may improve the quality of anesthesia induction and may allow better drug titration.Regarding air management herein, we found a significant difference between the 2 study arms. A noninvasive laryngeal mask was used more frequently for patients in the hypnosis arm , and on the day after surgery. Only fatigue was found to be significantly lower among patients in the hypnosis arm on the evening of surgery compared with patients in the control arm. We performed a subgroup exploratory analysis that took into account perception of hypnosis by the patients. Indeed, 25.0% (14 of 56) of patients in the control arm thought that they had received hypnosis, while only standard welcoming and patient care had been used by their staff members, who were not trained in hypnosis techniques. This emphasizes the difficulty in analyzing the specific and intrinsic effect of hypnosis vs a putative placebo effect. The subgroup analysis showed significantly lower postoperative fatigue and anxiety levels and better comfort/well-being in the perceived hypnosis subgroup compared with the no perceived hypnosis subgroup. To our knowledge, this is the first study to report such an effect of hypnosis on postoperative fatigue. In oncology, cancer-related fatigue is a frequently present and disabling symptom, which often influences patient quality of lifeP = .02]). A previous study7 showed that premedication with benzodiazepines did not improve the perioperative experience of patients when it was correlated with adverse effects, such as late extubation or a low early cognitive recovery rate, effects that have not been shown after hypnosis. Further studies are needed to objectivize and explain this higher global satisfaction and evaluate its causes, including simple attention and care linked to hypnosis or hypnosis-induced hormonal mediation influencing patient well-being.Patient satisfaction regarding anesthesia care and global management  was higher in the hypnosis arm (mean [SD], 8.9 [1.5] in the control arm vs 9.5 [1.1] in the hypnosis arm; 23Although not analyzed in our study, it may be possible that hypnosis has an effect on the operating staff members. In the hypnosis arm, patient preparation was performed with extra courtesy and in a low-noise and relaxed environment, which if studied may reveal a benefit on the whole team. Regarding the quality of life at work, it may be relevant to study this aspect and the effect of hypnosis on surgeons, nurses, and anesthesiologists in further studies.Our study has some limitations. As already discussed, the choice of surgery that induced limited postoperative pain is a major limitation and contributed to the negative primary end point of our study. Blinding may have decreased the effect of hypnosis because of hypnotic suggestion. Also, participation in the study may have caused a behavioral change among the medical and paramedical teams in the global care and management of patients, especially for patients in the control arm, who may have been cared for with more empathy than usual care. This may also have introduced a bias and decreased the difference in treatment group perception between the 2 arms and thus the effect of hypnosis in the hypnosis arm. Although patients in the control arm were prepared for surgery by staff not trained in hypnosis, a positive effect in addressing and caring for the patients makes it a limitation of the study.Our study shows no benefit of a short perioperative hypnosis session on postoperative pain in women eligible for minor breast cancer surgery. However, hypnosis seems to have other benefits regarding fatigue and anxiety, especially in patients who thought that they received hypnosis. Patient satisfaction is also improved with hypnosis. Further studies are needed to objectivize the benefit of hypnosis in this population.


Given the high rates of opioid addiction and overdose in the United States, non-opioid means of treating pain are increasingly needed. Transcutaneous electrical nerve stimulation (TENS) therapy is an effective non-opioid modality for treating pain, but has not yet been routinely used in emergency department (ED) settings. In this study we asked the following questions: Are TENS units a feasible treatment for pain in the ED? How effective are TENS units for the management of pain in a general ED population?At our institution, we performed a pilot study using TENS units for pain. Patients in the ED were given, at the discretion of the ED provider, TENS units for the treatment of pain. Patients could be included for acute or chronic pain on whatever part of the body that was safe to use with TENS.A chart review of patients receiving TENS units in the ED (n=110) revealed that TENS was useful in relieving pain, along with other treatments, in 99% of cases. When surveyed, 83% of patients reported a functional improvement while using the TENS, and 100% of patients would recommend a TENS unit to a family or friend. When surveyed, 100% of ED staff observed that TENS units were effective in treating pain for patients, and 97% would want to use them if they themselves were patients.Overall, in this small pilot study, TENS units appeared to be effective in our ED for reducing pain, when added to standard treatment. Additional studies are needed to determine which conditions are most responsive to TENS therapy, and the magnitude of pain reduction when used alone. With the high incidence of addiction, overdose, and death from heavy prescribing of opioids in the United States,There are multiple receptors in the periphery – pain, vibration, temperature, etc. – all of which transmit information to the brain via the spinal cord. The spinal cord fibers that transmit peripheral information cannot transmit information from multiple receptors simultaneously, and so the stimulation of multiple receptors at the same time results in decreased signal from each to the brain. TENS units, by providing a low-dose electrical current, stimulate vibration receptors, which when applied to an area having pain, reduces the transmission of painful stimuli to the brain.The goal of this study was to evaluate the efficacy of TENS units for the treatment of pain in the ED. The study questions were as follows: 1) Are TENS units a feasible treatment for pain in the ED?; and 2) How effective are TENS units for the management of pain in a general ED population? The project was a pilot program in our ED, and our study reflects the program evaluation. To the best of our knowledge, this is the first program to use TENS units on a routine basis for pain management in the ED, and represents the first study of using TENS therapy in the ED.This study was conducted at a suburban community hospital, with an annual ED census of approximately 56,000 yearly visits. The hospital developed a pilot study of using TENS units for pain management in the ED, and we report here the program evaluation of this project. The study was deemed a program evaluation by the hospital’s institutional review board committee, and therefore exempt from its approval.When the project was designed, we chose to offer TENS therapy to our providers as a pain management option in our ED. We did not specify whether or not TENS units could be used as mono-therapy or in combination with standard treatment for painful conditions in our ED. While the overarching goal was to provide effective pain relief without the need for opioids, this project was a feasibility pilot study to see if TENS units could be used routinely in our ED for pain management, along with other treatments. ED staff were informed that we were conducting a pilot study of using TENS units in our ED for pain management, but were not informed how we would be collecting data.We decided, when beginning the project, that we would collect data in three ways to evaluate the efficacy of our program: chart review of patients receiving TENS therapy; surveys of patient experience; and surveys of ED staff experience. Our study hypothesis was that as TENS units are effective in treating pain in multiple studies, TENS therapy for pain control in a general ED population would be, overall, effective in reducing pain. Our focus, given the preliminary nature of the study, was not to quantify the effect of pain relief, but rather to demonstrate that TENS could be used for pain control in an ED setting to support continuation of TENS therapy in our ED and provide preliminary positive study results to support additional, and more methodologically rigorous studies on the use of TENS units in the ED.Patients were included in the study if they met the following inclusion criteria: age over 15 presenting with acute or chronic pain in any area of the body, and open to trying a TENS unit for pain control. Patients were chosen to receive a TENS unit at the discretion of the treating provider in the ED. Exclusion criteria, contraindications, and precautions for the use of a TENS unit are listed in What do we already know about this issue?In the setting of the U.S. opiate epidemic, non-opiate pain treatment is desirable. Transcutaneous electrical nerve stimulation (TENS) therapy is an effective non-opioid treatment for pain.What was the research question?Are TENS units a feasible treatment for pain in the emergency department (ED), and if so, how effective are they in treating pain in a general ED population?What was the major finding of the study?In this small pilot study, nearly all patients (99%) had relief of pain in the ED with TENS therapy.How does this improve population health?Using TENS units for pain relief in the ED could reduce the need for opioids, while still treating pain.For those patients given a TENS unit, the patient’s name, age, medical record number, and email address (if available) were recorded for follow-up. The TENS units were applied by the treating provider to the area of greatest pain, guided by the following recommendations: First, when using the TENS unit, electrode pads should not be touching, and should be at least one inch apart. Second, the electrode pads should not be placed too far apart, as it reduces the efficacy of the therapy. Third, electrode pads should be placed surrounding the area of greatest pain, to allow for the electrical current to pass between the electrodes through the painful area.Patients received instructions from the manufacturer and instructions written by ED staff after reviewing how to use the unit. Patients were treated with the TENS unit for 20–30 minutes. Patients could receive any other medication or treatment to manage pain as directed by the treating provider. Patients could adjust the settings of the unit by themselves, or with assistance from ED staff. At discharge, the patient took the TENS unit home with them for further use.Our primary assessment of the efficacy of TENS units for pain management in our ED was chart review. An ED staff member performed a retrospective chart review of the cases in which a TENS unit was used, reviewing whether or not providers documented a response to the TENS unit, and whether or not the TENS unit was documented anywhere in the medical record as being helpful in relieving pain. We also recorded whether pain was acute or chronic, traumatic or atraumatic, and on which part of the body the TENS unit was applied. Acute pain was defined as less than three weeks in duration, while chronic pain was defined as three or more weeks in duration. Traumatic was defined as resulting from an acute traumatic injury, while atraumatic was defined as occurring in the absence of an injury.Data collection was done using a pre-prepared collection spreadsheet in Microsoft Excel  in a standardized fashion. Secondarily, we also surveyed patients who received TENS units and surveyed ED staff on their experience with TENS units. We sent out an anonymous email-based survey  eliciting patient feedback within one week of the ED visit to all patients who listed an email address. After four months of using the units, all ED staff received an anonymous, email-based survey (SurveyMonkey) eliciting their feedback on how well the units worked. Copies of both surveys are available as supplemental files. Data analysis was done using Microsoft Excel .The TENS unit used was made by AccuRelief , and the model was “Dual Channel TENS Electrotherapy Pain Relief System.”Between September 2017 and February 2018, 110 patients in our ED were treated with TENS units for pain management. Of those, 70 (64%) were female, and the average age of treated patients was 49 years. Patients who received a TENS unit varied in age from 15 to 92 years.In our chart review, in 97 out of 110 cases (88%) in which a TENS unit was used, the ED documentation reported how the patient responded to the TENS unit. In the remainder of cases, there was no documentation at all of the patient’s response to the TENS unit, merely that the patient had been treated with a unit.In 96 out of 97 (99%) cases in which the response to the TENS unit was documented, the TENS unit improved the patient’s pain. Information about the type of pain being treated is reported in For patient surveys, we had email addresses for 60 patients out of the 110 total patients who received a TENS unit, and 14 out of 60 patients (23%) responded to our email-based survey. Of the responders, 80% reported that they used their TENS unit multiple times after their ED visit. Zero patients required an opioid for pain relief when using the TENS unit; 92% of patients reported that they would use a TENS unit in the future. Of the patients surveyed, 100% said they would recommend a TENS unit to a friend or family, and 83% reported a functional improvement while using a TENS unit. Average pain scores from the survey are reported in For staff surveys, 35 out of 132 ED staff (27%) responded to our survey: 20% of respondents were ED techs, 45% were nurses, 29% were physicians, and the remainder were a combination of scribes and physician assistants. The surveys indicated that 100% of all ED staff reported they had observed TENS units improving pain in the ED; 100% of all ED staff reported that patients liked TENS units, and 97% of ED staff reported that if they were a patient in the ED with a sprained back, they would want to receive treatment with a TENS unit. Furthermore, 100% of ED staff would recommend a TENS unit to a friend or family member.In our pilot study, TENS units appeared to improve pain in ED patients, when combined with standard ED therapy. Between chart review, patient responses, and ED staff observations, TENS units were observed to improve pain and be useful in the treatment of pain in the ED.A TENS unit is an inexpensive and reusable device with few side effects for the management of pain; therefore, the device should be considered as a high-yield intervention for the treatment of pain in the ED, particularly in the setting of this nation’s opioid crisis and high rates of addiction. Our experience with this pilot study was that most ED providers are unfamiliar with the use of TENS units, creating a barrier to their use and implementation. In our ED, two providers (both are authors of this study) overcame this reluctance by championing the use of these devices, providing bedside teaching to all ED staff on how to use them, and developing protocols on their use. For departments considering using TENS units in their ED, one or more providers should consider taking the lead on implementing the project.The authors are aware of the limitations of the study, as will be formally discussed below, but would like to highlight that this pilot study presents data that support our hypothesis that TENS therapy for pain control in a general ED population would be effective in reducing pain. As such, our hope is that the results of this study will encourage other institutions to consider similar pilot projects in their own institutions, and stimulate further, and more definitive, study on the topic. As mentioned earlier, in our ED TENS units were used in addition to standard treatment. Some patients received only a TENS unit, while others received multiple medications, including opioids in some cases.Additionally, providers treated a wide array of complaints with TENS units, from humeral fractures and lumbar myofascial strains to chronic hip arthritis. As mentioned in the methodology section, our focus on the study was to prove that TENS units could be feasibly used in the ED setting for pain management, and that TENS units would be effective in reducing pain. Additional study to determine which types of pain and injuries respond best to TENS units would be useful to guide future implementation of programs for TENS therapy in the ED.This manuscript represents a pilot study at a single hospital on the use of TENS units for pain control, and has several limitations. First, providers did not document the response to a TENS unit in all cases, and not all patients or ED providers responded to our survey. As such, it is possible that there is a bias toward a positive effect, given that not all providers and survey recipients responded. As our online patient survey was anonymous, we could not track which patients who provided email addresses responded or did not respond, so we were not able to obtain any information on response bias by type of pain or other characteristic.Additionally, our study was not able to quantify the magnitude of pain relief with TENS as we did not quantify the amount of pain relief in our chart review. In the patient survey, the downward trending pain scores seen in the patients using TENS units who responded to our survey may represent the natural course of an acute myofascial injury such as a strain to improve over time rather than the effect of the TENS unit. We also chose to evaluate all complaints of pain, acute or chronic, in any part of the body. As such, we did not focus on which types of pain or locations of pain were most responsive to TENS treatment.Additionally, as this study lacks blinding or randomization, there may have been bias due to staff over-documenting positive results to TENS therapy, in the hope of creating a positive study. While this is possible, it is unlikely. Even though ED staff were aware that we were conducting a study of the use of TENS units, they were not informed of our collection methods beyond a survey of staff experience. Lastly, as ED providers had a large amount of freedom in choosing who received a TENS unit, it is possible that there was a bias, when deciding which patients should receive a TENS unit, toward patients who had a favorable perspective regarding these devices. A randomized, controlled, and blinded study design would yield more accurate data.In this small pilot study of using TENS units in a community hospital ED, we found that these units were effective, when used with standard ED treatments, in reducing pain. Additional studies with more robust methodology are needed to confirm the utility of this treatment modality to support widespread adoption, and focus on what types and locations of pain are most responsive to treatment.


Purpose: Post-operative pain and swelling are frequently observed after sinus lift procedures. The aim of the present study was the clinical evaluation of swelling and pain of two different sinus flap lift techniques using a visual analogue scale (VAS), verbal rating scale (VRS), and infrared thermal imaging . Materials Methods: A randomized controlled trial was conducted with 15 patients  randomly allocated into two groups. For the sinuses of Group I a trapezoidal flap was used, while for Group II a modified triangular flap without anterior release was utilized. Postoperative pain was scored by means of a 100-mm VAS ranging from 0 (no pain) to 100 (worst pain imaginable), and was recorded at 2, 4, 6 and 14 days after surgery. Swelling was recorded by a verbal rating scale (VRS) and was classified into four categories: a score of 1 referred the absence of swelling, patients with intra-oral swelling in the surgical zone scored 2, any extra-oral swelling in the surgical zone scored 3, and intense swelling exhibited by extra-oral swelling extending beyond the surgical zone scored 4. The facial temperature was recorded before and after sinus augmentation, and at 2, 4, 6, and 14 days post-surgery to check the course of healing. Results: In Group I pain intensity was recorded at 2 days after surgery with a mean score of 38.67 ± 6.4 mm. Swelling was greater at 2 and 4 days, and was absent at day 6. The facial temperature difference before and after the procedure was 4.737 °C ± 0.37. In Group II the pain score were lower than in Group I (p < 0.05). The score for swelling was 2 on the first and second days, and was reduced on day 4. After the second day the difference in temperature was significantly reduced as compared to the day of surgery (0.77 °C); at 2 and 4 days no difference was registered. Conclusions: The results of this clinical study show the significant effectiveness of the modified triangular flap in the sinus lift procedure for reducing pain and swelling. Post-operative pain and swelling are frequently observed after sinus lift procedures. Orofacial pain management is a challenging topic for the dental-medical profession .The placement of dental implants in the distal edentulous maxillary area is often a problem in case of the severely resorbed maxilla and presents a complex challenge to the oral and maxillofacial surgeon ,3,4,5. IMeanwhile, there is a positive correlation with the number of sinus walls in contact with the grafting material in cases of large sinus cavities because new bone formation starts from the residual crest and continues in a centripetal direction .The transcrestal approach as a treatment option may be preferred in case of narrow sinus cavities .The goals of sinus augmentation procedures are: formation of vital bone, implant integration in newly-formed bone, and long-term implant survival after functional load ,20,21,22Since there are a large number of bone substitutes available, the properties of these materials, related to biocompatibility and function in comparison to the gold standard, must be considered by surgeons in making recommendations and assisting in the patient’s treatment-planning process. Various grafting materials have been used for sinus augmentation: autologous bone, mineralized and demineralized freeze-dried allografts, coralline calcium carbonate, bioglass, polylactide-polyglicolide materials, synthetic polymers, calcium sulfate, anorganic bovine bone, and hydroxyapatite ,25,26,27The protocol for this study was designed in accordance with the Helsinki Declaration (revised version of Tokyo at 2004) and Good Clinical Practice Guidelines. It was approved by the Inter Institutional Ethics Committee of Faculdade Ingá, UNINGÁ, PR, Brazil, No. 72105917.5.0000.5220.Fifteen healthy patients with non-contributory past medical history  were included in this randomized pilot study. A total of 30 sinuses were randomly allotted into two groups (15 sinuses each). All patients (candidates for augmentation in the posterior maxilla) were scheduled to receive fixed prosthesis or crown restorations. All patients signed a written informed consent form. All patients were treated at the Department of Oral Implantology, Center for Advanced Studies, Dental Research Division, UNINGÁ—Cachoeiro de Itapemirim, Brazil. At the initial visit, all subjects underwent a clinical and occlusal examination. Panoramic radiographs were evaluated as well.The inclusion criteria were: edentulous or partly edentulous patients with a unilateral or bilateral loss of teeth in the maxillary premolar or molar areas, with severe alveolar atrophy and a residual alveolar ridge height of between 2 and 4 mm. The exclusion criteria were: severe illness, head and neck radiation therapy, chemotherapy, uncontrolled diabetes, uncontrolled periodontal disease, and smoking. Exclusion criteria also included facial or neck inflammatory skin diseases, carotid sinus hyperesthesia, hyperthyroidism, and patients who unilaterally declined undergoing post-operative treatment.Of these patients, one patient was totally edentulous in the maxilla, and 19 others were partially edentulous in the posterior maxilla. After a thorough oral and physical examination, patients were scheduled for bone reconstruction procedures, including sinus augmentation and implant insertion. Preoperatively, they were extensively informed concerning the surgical procedures and they were asked for their full cooperation during treatment. A three-dimensional radiographic examination (CBCT) before sinus augmentation was performed on all patients to identify clinically relevant and radiographically evident pathologies such as mucosal thickening, allergic sinusitis, odontogenic sinusitis, mucus-retaining cysts partial to complete sinus obliteration, oroantral communications, antroliths, mucoceles, and mucopyoceles. CBCT was also used confirm the patency of the ostium and the osteomeatal complex.All patients were treated in the Outpatient Department of Oral Implantology, Center for Advanced Studies, Dental Research Division, UNINGÁ—Cachoeiro de Itapemirim, Brazil, and 39 implants were placed after six months of healing. All patients were evaluated for 14 days. The sites were randomly assigned to the test or control group by a computer-generated table, which was prepared using a balanced, randomly permuted sinus approach. We used free random sampling and random assignment application . All sinus lifts were performed by a single operator, experienced in performing both the trapezoidal (TZ) flap  and the Postoperative pain was scored by means of a 100-mm visual analogue scale (VAS) from 0 (no pain) to 100 (worst pain imaginable) at 2, 4 and 6 days in the first week post-surgery and then at 14 days. Pain intensity was classified into four categories. Swelling was recorded by verbal rating scale (VRS). In this scale, swelling was classified into four categories: a score of 1 referred to the absence of swelling, patients with an intra-oral swelling in the surgical zone scored 2, any extra-oral swelling in the surgical zone scored 3, and intense extra-oral swelling extending beyond the surgical zone scored 4 . At each®  associated with epinephrine 1:100,000. Full-thickness flaps were elevated to expose the alveolar crest and the lateral wall of the maxillary sinus. Using a round bur under cold (4–5 °C) sterile saline irrigation, a trap door was made in the lateral sinus wall. The door was rotated inward and upward with a top hinge to a horizontal position. The sinus membrane was elevated with curettes of different shapes, until it became completely detached from the lateral, inferior, and medial walls of the sinus. The maxillary sinus was filled with sterilized bovine bone particles mixed with venous blood . No perforation of the sinus membrane was evident in 25 of the cases. A small perforation was evident in five cases, two in group I and three in group II. All small perforations appearing in the sinus membrane were repaired with autologous platelet gel [Prior to surgery, patients rinsed with a chlorhexidine digluconate solution 0.2% for 2 min. Local anesthesia was obtained with Articaineelet gel . Flaps wSutures were removed two weeks after surgery. Follow-up surgical visits were scheduled at 2, 4 and 6 days in the first week and at 14 days to check the course of healing. The recall program included assessments of VAS, VRS, and facial temperature assessment.Thermal measurements were performed in a climate-controlled room .Facial temperature of the operated side was obtained using a 14-bit digital infrared camera . The acquisition parameters were: 320 × 240 pixels focal plane array; 8–9 µm spectral range; 0.02 K noise equivalent temperature differences (NETDs); 50-Hz sampling rate; optics: germanium lens; f 20; and f/1.5. The camera was set 0.50 m away from the face for maximum spatial resolution. Images were acquired at a rate of 25 per second and subsequently re-aligned using an edge-detection based method implemented with in-house software. Temperature changes in the face were computed on the realigned thermal images. Thermographic data analysis was performed using FLIR QuickReport v.1.2 , which includes a tool to obtain maximum, minimum, and average temperature of a user-defined area. The facial areas of interest were the malar and cheek areas.A power analysis was performed using clinical software for determining the number of sinus needed to achieve statistical significance for quantitative analyses of VAS, VRS, and facial temperature. A calculation model was adopted for dichotomous variables (yes/no effect) by using the effect incidence designed to discern the reasons (85% for the TZ flap and 15% for the MT flap), with alpha = 0.05 and power = 80%.The optimal number of samples for analysis was 14 sinus augmentations.The correlation between temperature and pain at each time was assessed by a linear regression model; to assess the correlation of measurements throughout time, mixed effect repeated measures were performed. To evaluate the differences in the VAS, VRS, and facial temperature between the groups, one-way ANOVA statistical analysis was used. A value of 𝑝 ≤ 0.05 was considered to be statistically significant. Data treatment and statistical analysis were done by Excel  Origin  and SPSS software .The trial is registered on the Brazilian Clinical Trials Registry/Registro Brasileiro de Ensaios Clínicos (ReBEC) (UTN: #U11111-1202-3138).All augmented sinuses healed well with no occurrence of symptoms indicating possible maxillary sinusitis. Based on the VAS scores, peak pain intensity was recorded at 2 days after surgery with a mean score of 38.67 ± 6.4 mm A,B. AfteThe difference in temperature before the procedure  and immediately after sinus augmentation was 1.55 °C . The difNo postoperative paresthesia or signs of infection were seen during the entire healing period.All augmented sinuses healed well with no occurrence of symptoms indicating possible maxillary sinusitis. The clinical healing of the surgical area was uneventful in all patients. Wound dehiscence or infection were not observed in any of the cases. The VAS pain scores were mild on the second and fourth day and were lower than in Group I. The pain intensity was recorded at 2 days after surgery with a score of 29.33 ± 7.03 mm, which is mild . At fourThe difference in temperature increased on day 2 C,D, and p = 0.0004), 4 days (p = 0.002), and 6 days (p = 0.01); no differences were found at 14 days.Significant differences in VAS scores were found between the two groups at 2 days (p = 0.000018), 4 days (p = 0.0008), and 6 days (p = 0.009); no differences were found at 14 days.Significant differences in VRS scores were found between the two groups at 2 days (p = 0.00013), at 2 days (p = 0.003) and at 4 days (p = 0.02); no differences were found at 6 days (p = 0.18) and at 14 days.A significant difference in temperature was found between the two groups before and after surgery  and calculation of the amounts of analgesics consumed . SwellinTo overcome these difficulties, we used infrared thermography. This has been used for the evaluation of temperature during implant preparation  and the In the present study, the two control and test groups were uniform with respect to given factors; the patients were chosen in the same age range, the groups had approximately the same number of men and woman, and the durations of the surgeries were all between 20 to 25 min. All the patients were prescribed similar pharmacological therapy. In fact, skin temperature is the most important method to determine the presence of tissue swelling and inflammation. The flap design is important in oral surgery. In fact, the ultimate goal in sinus surgery is not only the bone augmentation but also the preservation of periodontal tissue, use of suitable surgical techniques, and the reduction of postoperative swelling. Usually, in sinus surgery with a lateral approach, full-thickness mucoperiosteal flap elevation with a crestal and bi-lateral oblique releasing mesial and distal incision is used. However, this could also interfere with the blood supply from the vestibule and might inhibit adequate blood supply to the flap. The vascularization of the maxilla and buccal vestibule maxilla is densely vascularized by two vessels: the posterior superior alveolar artery and the infraorbital artery. The infraorbital artery reaches the face through the infraorbital foramen and supplies the lower eyelid, cheek, and lateral nose. It anastomoses with branches of the transverse facial, ophthalmic, buccal, and facial arteries . The maxThe flap should be designed to minimize disturbance of the blood supply, and the surgical site needs to be securely covered . IdeallyThe results of this clinical study show significant effectiveness of the modified triangular flap in the sinus lift procedure for reducing pain and swelling. It is probable that the posterior passive drains reduce swelling and pain when the modified triangular flap is used. In fact, the distal relieving incision was left without sutures. This passive drain promotes the spontaneous leaking of the inflammatory exudate and reduces postoperative swelling and pain. The MT flap cannot damage the lateral blood supply, which runs in a posterior to anterior direction . In partIn conclusion, a modified triangular flap can be used with success in sinus augmentation procedures and is preferable to the trapezoidal flap.