The perfusion index change ratios did not significantly differ between the groups. The intraoperative perfusion index change ratios do not correlate with acute postoperative pain following laparoscopic colorectal cancer surgery.Despite technical advancements in the perioperative management of cancer surgery, postoperative pain remains a significant clinical issue. We examined the diagnostic value of the intraoperative perfusion index for predicting acute postoperative pain in patients undergoing laparoscopic colorectal cancer surgery. We retrospectively analyzed data for 105 patients who had undergone laparoscopic colorectal cancer surgery. Patients with pain scores <7 and ≥7 on a 10-point scale upon arrival in the postoperative anesthesia care unit (PACU) were categorized into the N and P groups, respectively. The perfusion index value was extracted prior to intubation, at the start and end of surgery, and after extubation. To minimize individual variance in the absolute value of the perfusion index, we calculated the perfusion index change ratio. A total of 98 patients were examined. Among them, 50 (51.0%) and 48 (49.0%) patients reported pain scores of <7 and ≥7 upon arrival at the PACU, respectively. Fentanyl consumption during the intraoperative and PACU periods was significantly higher in Group P than in Group N ( Despite technical advancements in the perioperative management of cancer surgery, postoperative pain remains a significant clinical issue . Previouhttp://cris.nih.go.kr/cris/index.jsp). We retrospectively reviewed the electronic medical records of patients who underwent elective laparoscopic colorectal surgery from January 2019 to April 2019 at a single center. The patients ranged in age from 28 to 82 years. All patients had tumors within the colon or rectum and had undergone laparoscopic colectomy or anterior resection. The exclusion criteria were as follows: preoperative pain therapy, emergent surgery, recurrent colorectal lesions, metastatic colorectal lesions, conversion to open surgery, a lack of follow-up data, need for intensive care unit management after surgery, and inability to express pain severity. This study was approved by our departmental ethics committee (ref: SMC 2019-06-047) and registered with Clinical Research Information Service of the Korea National Institute of Health, ref: KCT0004096,  of the index finger. It was placed on the hand contralateral to the side of the blood pressure cuff. All surgeries were performed by one of six specialized colorectal surgeons who followed similar techniques for colorectal cancer. Approximately 20 min before the end of surgery, patients received an intravenous patient-controlled analgesia pump , which delivered 25 µg/kg of fentanyl in normal saline (100 mL) at a basal infusion rate of 0.5 mL/h and a bolus of 1 mL. The lock out interval was 15 min. At the end of surgery, 0.03 mg/kg of intravenous pyridostigmine and 0.002 mg/kg of intravenous glycopyrrolate were administered to the patients. After extubation, patients were moved to the postoperative anesthesia care unit (PACU). They received a further bolus of intravenous fentanyl at 0.5 µg/kg when visual analogue scale  scores were greater than 3 [Patients were not preoperatively medicated. Intraoperative anesthetic management was standardized. Standard monitoring  was performed and included oxygen saturation, electrocardiography, end-tidal carbon dioxide, pulse oximetry, bispectral index (BIS), and non-invasive blood pressure measurements. Anesthesia was induced intravenously with 40 mg of 2% lidocaine, 2 mg/kg of 2% propofol, 0.5–1 µg/kg of fentanyl, and 0.6–0.8 mg/kg of rocuronium. Endotracheal intubation was performed using a Macintosh laryngoscope after approximately 3–5 min of mask ventilation and the loss of all four twitches following train-of-four stimulation of the ulnar nerve. After tracheal intubation, anesthesia was maintained with 1.5–3.0 vol. % sevoflurane and a bolus injection of 0.5–1 µg/kg of fentanyl to maintain hemodynamic parameters within 20% of baseline values and a BIS of 40–60. The lungs were ventilated with 50% oxygen with air. This was adjusted to maintain an end-tidal carbon dioxide level of 30–40 mmHg. Body temperature was controlled at a target value of 36.5 °C. During anesthesia, the PI was continuously monitored via pulse oximetry . Data are expressed as means ± standard deviations (SD) or numbers (with percentages), as appropriate. Demographic and clinical data for the two groups were compared using a Chi-square test, a t-test, or Fisher’s exact test. We extracted PI values prior to anesthesia (T1), at the surgical incision (T2), at the end of surgery (T3), and after extubation (T4). To minimize individual variance in the absolute values of the PI and BIS, we calculated PI change ratios (PI at each time point − PI at T1/PI at T1) and BIS change ratios (BIS at each time point − BIS at T1/BIS at T1) at T2, T3, and T4. These ratios were compared using t-tests. In each group, differences in PI and BIS values over time were compared using a generalized estimating equations (GEE) analysis. The level of statistical significance was set at p = 0.803) or BIS values (p = 0.222) at any time point (Of the 105 patients assessed for eligibility, seven were excluded due to insufficient medical records. Thus, data were analyzed for a total of 98 patients. Demographic and clinical data are summarized in me point . In bothme point , (Table me point . The datme point .In the present study, we aimed to determine whether intraoperative PI values correlate with acute postoperative pain in patients undergoing laparoscopic colorectal cancer surgery. However, there were no significant differences in PI change ratios over time between patients with pain scores <7 and those with pain scores ≥7.During anesthesia, balanced analgesia is critical for reducing postoperative pain and analgesia related side effects . Under- In the present study, intraoperative PI change ratios did not correlate acute postoperative pain. PI values significantly increased following the induction of anesthesia due to decreased sympathetic tone. These values decreased following surgical incisions due to increased sympathetic tone and decreased further after extubation due to acute postoperative pain, anxiety, or agitation. BIS values exhibited an inverse pattern when compared with PI values. Because there were no significant differences in PI or BIS change ratios and no relationship between mean PI and BIS values over time, the depth of consciousness might not be related to the PI during anesthesia. We suspect that general anesthesia agents may overcompensate for intraoperative sympathetic changes due to surgical stimuli, which may influence changes in PI values. Alternatively, differences in the pathophysiology of acute and chronic pain may explain the poor predictive capacity of intraoperative PI values. Chronic pain may be related to autonomic disturbances, as previous research has indicated that PI values are associated with improvements in pain after lumbar transforaminal block in patients with chronic lower radiculopathy . In a raThis study had several limitations. First, we did not measure PI values in the PACU due to poor patient cooperation. PI measurements are quite sensitive to patient, probe, and tissue movements, which may cause rapid fluctuations in PI values. Second, we did not rule out preoperative psychosocial factors including anxiety, depression, sleep disturbances, and stress . Third, The results of the present study suggest that PI change ratios do not correlate with acute postoperative pain in patients undergoing laparoscopic colorectal surgery. Future prospective randomized studies are required to determine whether more targeted parameters can provide superior diagnostic value for nociception under anesthesia.


Although sedatives can defuse anxiety and relieve pain, Esophagogastroduodenoscopy (EGD) still is uncomfortable and threatening for some patients. Identifying patients who tolerate digestive endoscopy less well remains difficult. Using a prospective design and a multimodal assessment of pain, the present study evaluated how anxiety-related variables predicted subsequent pain outcomes. Sixty-two consecutive patients referred for elective EGD were assessed for intolerance of uncertainty (IU), procedure-related worries, anxiety sensitivity and health distress before endoscopy. During endoscopy, a doctor rated patients’ pain behavior. After complete recovery from sedation, the patients retrospectively rated endoscopy pain and situation specific catastrophizing thoughts. Descriptive analyses showed that patients undergoing EGD for the first time were more distressed and anxious than patients accustomed to the procedure and needed a higher sedative dose. Notwithstanding sedation, the behavioral rating of pain was above the cut-off value for probable pain for more than half of the patients. IU assessed before endoscopy predicted situational pain catastrophizing (PC) and self-reported pain after endoscopy through procedure related worries. Situational PC not only mediated the effect of worry, but also female gender and younger age were associated with self-reported pain through increased catastrophizing thoughts. Health distress and anxiety sensitivity predicted PC only for women, younger patients, and those not accustomed to the procedure. Our study showed that psychological preparation before sedation is needed especially for first-timers, women, and younger patients, addressing maladaptive cognitive beliefs and acquainting patients with the somatic sensations that they might experience during the procedure. Esophagogastroduodenoscopy (EGD) is a diagnostic procedure carried out using a flexible probe equipped with a camera, which allows the mucous membrane of the esophagus, stomach, and duodenum to be explored visually. The examination lasts a few minutes, is safe, and has many benefits, such as accurate diagnosis and guidance on effective interventions for upper gastrointestinal conditions. Although EGD is well tolerated, the patients may experience mild to moderate discomfort, and the prospect of inserting the probe through the oral cavity, then sliding it into the stomach, may evoke fears such as that of unpleasant physical sensations, adverse diagnostic outcomes , and insufficient sedation . BecauseConscious sedation reduces patient anxiety and discomfort e.g.,  but is nThere is a need to prioritize patients who are at greater risk of experiencing clinically relevant anxiety, targeting those to be psychologically prepared according to their needs and personality characteristics. Female gender, younger age, and no previous endoscopy experience are known risk factors for pre-procedural anxiety and low EGD tolerability . HoweverIntolerance of uncertainty (IU) is a cognitive disposition involved in the emergence and maintenance of anxiety disorders and depression, influencing how people react to uncertain events, however unlikely, appraising them as unfair, unacceptable, and threatening . Worryinabsence of information at any level of consciousness” . This definition is consistent with evidence showing that “first-timers,” lacking experiential information about the procedure, tend to feel greater anxiety than “repeaters”  is a third cognitive construct that might be involved in the relationship between procedural anxiety and EGD tolerability. PC is a mindset of exaggerated negative cognitions and emotional schemas that describe people’s beliefs, appraisals and feelings related to actual or expected pain experience . As a muSimilar to IU and anxiety sensitivity, PC has long been considered a dispositional trait involved in the maintenance of chronic pain and disability . HoweverHow IU, anxiety sensitivity and PC shape patient’s experience of EGD? Previous research has overlooked the role of these cognitive characteristics. Moreover, no single study has assessed IU, anxiety sensitivity and PC in EGD patients, nor has examined the predictive role of psychological variables using a two-stage prospective design. As shown in Because IU is known to lead to excessive preoccupation, we hypothesized a direct relationship of this variable with EGD worries (H1). According to the transdiagnostic hypothesis, we also expected IU to be linked with patient’s health-distress (H2), operatively defined as a combination of depression and anxiety feelings before the procedure. Because IU entails a more general fear of the unknown than anxiety sensitivity, we also hypothesized that the greater the fear of the unknown, the greater the fear of the unknown consequences of procedure-related anxiety (H3). According to H4–H6, we expect that the set of cognitive variables can predict situation-specific catastrophizing thoughts reported by the patients after the procedure. PC has a central role in our model. We expect situation specific catastrophizing thoughts to magnify the experience of pain during the EGD (H7) and lead to greater pain reporting after EGD (H8).The model also considers female gender, younger age, and no previous endoscopy experience as external sources that can predict the intensity of pain and PC (H9a-i). Adding these variables to the model has several advantages. First, it allows for controlling the effects of known risk factors for pre-procedural anxiety and poor EGD tolerability. Second, it allows studying their moderation effects on the relationships between psychological and pain variables. Moderation effects in a predictive model test “under which circumstances” or “for whom,” an independent variable is more (or less) strongly associated with the outcomes. For instance, if the moderation effect of gender on the relationship between anxiety sensitivity and PC turns out statistically significant, that entails anxiety sensitivity to be differently predictive of PC for men and women.Inclusion criteria for the study were age over 18 years and knowledge of the Italian language. Exclusion criteria were a history of psychiatric disorders, use of antidepressants, adrenoreceptor antagonists, or opioids, current or recent chronic pain syndrome. Eighty consecutive outpatients referred for EGD at the Endoscopy Unit of “Sapienza” University of Rome were eligible for the present study. Seven patients refused to participate (9%). Five (6%) and two (3%) patients did not complete the psychological scales before endoscopy and refused to answer pain questions after endoscopy, respectively. Four patients (5%) were excluded because of a history of psychiatric disorders or current use of medications.M = 58.24; SD = 14.88). Of the 62 patients referred for EGD, only five patients had signs of serious diseases . The remaining 57 patients were either symptomatic  or follow-up after surgery (n = 14). The EGD lasted on average 7.43 min (SD = 5.38) and were performed under conscious sedation using a standard endoscope. Patients received a dose of 2–5 mg of midazolam, with a dosage protocol of 0.07 mg/kg. The BMI ranged from 16 to 35 kg/m2 . Considering the BMI normal range 18–25, one patient was underweight, 24 were overweight, and five were obese . The final endoscopic diagnosis was categorized as inflammation , lesion , other conditions , or negative endoscopy (n = 3). Because of an incomplete EGD, the diagnosis was unknown for one patient.The analyses were carried out on 62 patients (31 women and 31 men), 35 (54%) of which had previous EGD experience. The mean age of the sample ranged from 25 to 86 years . The psychologist was in the room and assisted the patient upon request. A progressive ticket number was assigned to each patient that had to be delivered to the endoscopist doctor in the operating room. Before endoscopy, the doctor verified the absence of exclusion criteria for the study, transcribed patient’s anamnestic data, and then proceeded to the EGD. Only one endoscopist was involved in the study and performed all the exams. During endoscopy, a specializing doctor observed the patients and rated patient’s pain and sedation level. The specializing and the endoscopist doctors were blinded to the patient’s answers to the psychological scales administered before endoscopy. After complete recovery from sedation, the endoscopist doctor invited the patient to answer questions about pain and situational PC, which were placed with the anamnestic data into a sealed envelope on which the patient’s progressive number was transcribed. This study was carried out in accordance with the recommendations of the Code of Ethics for Research in Psychology, Italian Association of Psychology. The protocol was approved by the Ethical Committee of the Department of Dynamic and Clinical Psychology, “Sapienza” University of Rome. All subjects gave written informed consent in accordance with the Declaration of Helsinki.The Hospital Anxiety and Depression Scale (HADS) includes seven items for anxiety and seven for depression symptoms, each rated on a 4-point severity scale. The total score is a valid measure of health distress . In the The Italian version of the Intolerance of Uncertainty Inventory (IUI-A) is a 10-item scale developed to assess the tendency for a person to consider uncertainties in life to be unacceptable and threatening . The iteThe ASI-3 Italian version  is an 18To capture cognitive activity associated with pre-procedural anxiety, we developed a Worry for Medical Procedures Scale (WMPS) by rewording the items of the Penn-State Worry Questionnaire  in the cBecause the patient was unable to communicate during EGD, we rated the pain responses during endoscopy using the Pain Assessment in Advanced Dementia Scale PAINAD; . A medicPain intensity was assessed using visual-analog, numeric, verbal, and face scales. The Visual Analog Scale (VAS) required the patient to place a mark on a 10 cm long horizontal segment that went from “no pain” to “worst imaginable pain.” There were no words on the segment between the two ends. We obtained a continuous score in centimeters, ranging from 0 to 10. The numeric scale asked the patient to evaluate how painful was the procedure using integer numbers from 0 to 10, with higher numbers indicating lower pain intensity. The numeric response scale was intentionally reversed to prevent carryover effect. The score was reversed before the analysis. The verbal scale included five verbal descriptors placed in a ranked order. Very severe, severe, moderate, mild, very mild, and no pain was coded using numbers from 5 to 0, respectively. Last, patients were asked to report the experienced pain selecting from six drawings of facial expressions of pain.To capture catastrophizing thoughts occurring during EGD, we used the same items included in the Italian version of the dispositional PC Scale , changinWe performed a partial least squares structural equation modeling analysis (PLS-SEM) using Smart PLS 3 . PLS-SEMThe model evaluation comprises two stages: the assessment of the “measurement model,” dealing with the relationships between the empirical indicators and the latent variables, and the evaluation of the “structural model”, which represents the direct and indirect relationships between latent variables. Four quality criteria determine the adequacy of the measurement model. First, all indicators variables should load on the corresponding latent variables above 0.50 (indicator reliability). Second, the Composite Reliability (CR) of each latent variable should be at least above 0.60, or preferably above 0.70 (construct reliability). Third, the Average Variance Extracted (AVE), measuring the proportion of variance in the indicators that is accounted for by the corresponding latent variable, should be 0.50 or higher . Last, the square roots of the AVE for each latent variable should be larger than the estimated correlations of that latent variable with other variables in the model .R2) for the endogenous latent variables. According to R2-values of 0.75, 0.50, and 0.25 represent high, moderate, and low thresholds, respectively. The predictive accuracy of the model is also evaluated in terms of cross-validation. For this purpose, a Q2 cross-validation index is obtained for each endogenous variable using a blindfolding procedure assessing the ability of the model to predict omitted data not used for estimation .Notwithstanding sedation, the behavioral rating of pain score was above the cut-off value for probable pain for 29 patients (53%). No differences were found by gender and EGD experience . Howeverps < 0.05, one-tailed). Similarly, first-timers referred to be more worried than experienced patients, regarding the procedure and its clinical outcomes . Women also reported more concerns about the procedure than men .Intolerance of uncertainty, anxiety sensitivity, worry, and health distress were highly correlated. But the coefficients were not so large as to suggest an overlap of the constructs. Moreover, each of the psychological variables had specific relationships with the pain variables. IU and worry before EGD were associated with situational PC and self-reported pain after EGD. Health distress was significantly associated with situational PC, only. By contrast, anxiety sensitivity was correlated with all pain variables. The inspection of the correlation coefficients suggested that situational PC seemed to have a pivotal role, being significantly associated with all the psychological variables before EGD, and with the behavioral rating of and self-reported pain, during and after the procedure, respectively. As in previous descriptive analyses, female gender was significantly associated with anxiety sensitivity, while no previous endoscopy experience was related to greater health distress and worry. Older age was also negatively correlated with PC and self-reported pain.R2 and Q2 statistics for the endogenous variables. The model accounted for 49, 39, and 24%  of the variance in anxiety sensitivity, health distress, and EGD-related worry, respectively. IU was significantly associated with anxiety sensitivity (2f = 0.97), health distress (2f = 0.64), and worry (2f = 0.32). The model explained 54% (p < 0.001) and 42% (p < 0.001) of the variance in situational PC and self-reported pain, respectively. The prediction was not significant for pain behavior during EGD . According to Q2-values were all positive, supporting the robustness of the model in terms of cross-validation.2f = 0.07). Regarding pain variables, the model showed that pain behavior during EGD predicted situation specific catastrophizing thoughts (2f = 0.34), which in turn were associated with self-reported pain after EGD (2f = 0.34). Female gender and patient’s age also predicted PC . Unexpectedly, the patient’s experience with EGD did not predict any of the pain variables. In addition to testing specific path coefficients, the model allowed us to examine several indirect relationships among variables. Situational PC mediated the effect of pain behavior , gender , age , worry  on self-reported pain. Moreover, worry mediated the effect of IU on situational PC .Different from the correlations reported in Younger age and female gender, but not EGD experience, were associated with higher PC. Nevertheless, previous descriptive analyses had shown that first-timer patients tended to be more distressed before EGD and required higher doses to attain acceptable levels of sedation, too. Notwithstanding this, neither anxiety sensitivity nor health distress predicted situational PC. Neither, EGD experience seemed to play any role in the model. It is still entirely possible that the prediction of pain outcomes might depend on the interactive effects of psychological characteristics with age, gender, and EGD experience.Using the available data, we tested specific hypotheses concerning the role of EGD experience (as well as those of age and gender) as factors that might alter the average level of PC as a function of anxiety sensitivity, worry, and health distress. As one can see from Because a moderation effect could be very informative about “under which circumstances” or “for whom,” an independent variable is more (or less) strongly associated with the outcomes, we examined the simple slopes for situational PC on the three independent variables for men and women, first-timers and repeaters, and younger and older patients. As one can see from Being focused on anxiety symptoms, previous research has overlooked the role of their cognitive antecedents, which lead patients to experience overwhelming anxiety before EGD, misinterpret uncomfortable physical sensations, and increase the risks and the costs associated with over-sedation . Using aFirst of all, our study showed that IU assessed before endoscopy was associated with situational PC and self-reported pain after endoscopy. Paralleling previous research on anxiety disorders , our mulA second major finding of the study was that situational PC had a pivotal role in the chain of events that lead to low tolerability. Not only it mediated the effect of worry, but also female gender and younger age were both associated with self-reported pain through increased catastrophizing thoughts. Foreshadowing the discussion of the clinical implications, it looks like that PC thoughts during endoscopy were likely responsible for low tolerability for these specific groups of patients . Our finPatient’s health distress and anxiety sensitivity were significantly associated with situational PC in bivariate analyses. Also, anxiety sensitivity was correlated with evident pain behaviors during endoscopy. However, subsequent analyses showed that these correlations did not yield significant regression paths in multivariate analyses. Different from worry, the prediction of PC by health distress and anxiety sensitivity was moderated by the other known risk factors for low tolerability. In particular, the two anxiety-related variables affected subsequent catastrophizing thoughts only for women, younger patients, and those not accustomed to the procedure. These findings corroborate previous research aimed at identifying which patients tolerate digestive endoscopy less well  and suggThe lack of information about what might happen during a medical procedure is an important distressing factor, able to activate cognitive distortions in the appraisal of threat . In keepAlthough EGD is typically well tolerated under conscious sedation, our study showed that more than half of the patients were above the cut-off value for probable pain using a behavioral rating scale. Because most patients attained an adequate level of sedation, it is worth asking whether the patients coped with a “real pain” or just misjudged unpleasant physical sensations as pain . PreviouBefore concluding it is worth acknowledging some limitations of the present study. First, the sample size was relatively small. Although the number of patients was adequate for performing non-parametric analyses, it precluded us from controlling other qualitative variables potentially influencing pre-procedural anxiety, like motives for a referral to the endoscopy center or final diagnosis after endoscopy. Second, PC and self-reported pain were both assessed after the procedure. This might threaten the directional interpretation of our findings concerning the prediction of self-reported pain based on a concurrent assessment of PC. Last, we recruited patients at only one university clinic, and only one endoscopist performed all exams. Thus, the findings of the present study should be cautiously interpreted regarding their generalizability to smaller clinics, private diagnostic wards, or less skilled operators.Its limitations notwithstanding, our study is the first to address the interplay of IU, anxiety sensitivity and PC in relation to EGD tolerability. Moreover, our findings may enable identification of potential avenues for psychological intervention in the endoscopy setting. While relaxing music or aromatic care have been suggested to defuse procedural anxiety e.g., , these iAlthough promising, none of the studies mentioned above has targeted IU, anxiety sensitivity and PC, nor considered pain as the primary outcome. An avenue for future research could be designing interventions in which patient training is aimed to replace negative beliefs with positive coping self–statements , that is a recommended strategy to cope with acute pain through psychological preparation . InterveThe datasets generated for this study are available on request to the corresponding author.All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.This manuscript updates and extends a preliminary research report presented at the Digestive Disease Week 2018. The final version of this manuscript was written by ML, MT, and SP, who contributed equally to the theoretical and empirical aspects of the study. RP contributed to the collection and analysis of medical data and wrote a preliminary version of this manuscript. GL and AF collected and analyzed the psychological data. CP and MR collected and analyzed the medical data.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The handling Editor declared a past co-authorship with one of the authors MT.


Out-of-hospital analgosedation in trauma patients is challenging for emergency physicians due to associated complications. We compared peripheral nerve block (PNB) with analgosedation (AS) as an analgetic approach for patients with isolated extremity injury, assuming that prehospital required medical interventions  using PNB are less painful and more feasible compared to AS.Thirty patients (aged 18 or older) were randomized to receive either ultrasound-guided PNB  or analgosedation (midazolam combined with s-ketamine or with fentanyl). Reduction-feasibility was classified  and pain scores were assessed using numeric rating scales (NRS 0–10).Eighteen patients were included in the PNB-group and twelve in the AS-group; 15 and 9 patients, respectively, suffered dislocation injury. In the PNB-group, reduction was more feasible  compared to the AS-group . During medical interventions, 5.6% [1/18] of the PNB-patients and 58.3% [7/12] of the AS-patients experienced pain (p<0.01). Recorded pain scores were significantly lower in the PNB-group during prehospital medical intervention (median[IQR] NRS PNB: 0[0–0]) compared to the AS-group  as well as on first day post presentation . All patients of the PNB-group would recommend their analgesic technique .Prehospital ultrasound-guided PNB is rapidly performed in extremity injuries with high success. Compared to the commonly used AS in trauma patients, PNB significantly reduces pain intensity and severity. Joint luxation and dislocated fractures are frequently encountered in prehospital patient care and are often associated with extreme pain. Although pain is usually the most dominant presenting complaint in patients admitted to the emergency room, this symptom is commonly undertreated with “oligoanalgesia” especially in trauma victims . An explIn this study, we examined the application and analgesic efficacy of ultrasound-guided PNB in prehospital trauma patients who present with injuries to the extremities. We hypothesize that in patients with an isolated injury of an extremity, the prehospital use of PNB will result in significantly lower pain scores on the day of trauma and the following two days, as well as improving the reduction-feasibility of dislocated injuries compared to that in patients who had received AS alone.Deutsches Register klinischer Studien under the clinical trial number DRKS00009541 on February 09, 2016. The study was conducted within the Emergency Medical Services and the Helicopter Emergency Medical Services of Goettingen by emergency physicians (EP) of the Department of Anesthesiology of the University Medical Center Goettingen. The protocol for this trial  and was registered at the is trial  and CONSis trial  are avaiGerman Society of Anesthesia and Intensive Care (DGAI) to practice ultrasound-guided regional anesthesia. At the point of first contact, a structured physical examination was performed for all patients. Standard clinical monitoring was established  and peripheral venous access was ensured. By the toss of a coin at the scene of accident, patients were randomly assigned to the study group (PNB) to have a PNB proximal to injury location or to the control group (AS) for AS alone. Motor function, vascularisation and sensitivity of the injured extremity were examined before analgesic procedure and after the required medical intervention at the scene of accident.During a one-year period , 30 prehospital trauma patients aged 18 years or older were included in the study. Inclusion criteria were an isolated injury of an extremity, causing pain  and requiring a prehospital medical intervention . Patients had to be able to give informed consent. Exclusion criteria were any preexisting nerve damages of the extremities or known allergy to local anesthetics. At the scene of the accident, verbal informed consent for participation in the study was obtained. A written consent was later obtained during the course of hospital stay. Prehospital treatment of patients was managed by two EPs , who work also as consultant anesthetists and are certified by the Intravenous analgesia was usually performed by the attending EP using a standard technique of s-ketamine  combined with midazolam (0.05 mg/kg BW). In some cases, fentanyl was combined with midazolam administered by the previous acting EP. In the event of additional demand for the trial EP of Helicopter Emergency Medical Services by this previous acting EP, the doses were adjusted to AS already administered  to avoid mixture of several narcotic drugs and subsequent adverse events.A combination of femoral nerve block  and sciatic nerve block  was performed for below-knee and foot injuries. Injuries of the thigh or patella were treated with a femoral nerve block. An interscalene brachial plexus block  was performed for the injuries of the upper extremity involving the shoulder and upper arm. Forearm injuries were treated with infraclavicular brachial plexus block . Therefore, the respective targeted nerve/trunks/fascicles were located by ultrasound . To ensure safe aseptic conditions, the PNB-procedures were conducted according to standard operating procedures that are comparable to those used in emergency departments. The puncture site was disinfected and anesthetized with 1% mepivacaine. The EP used steril gloves. Under ultrasound guidance, a 19 G stimulating cannula  was directed to the respective nerve/trunks/fascicles. After confirmation of correct needle tip position by ultrasound, 10 mL of prilocaine (1%) and 10 mL of ropivacaine (0.2%) were injected (single injection technique) until the entire circumference of the nerve/trunks/fascicles was shown to be surrounded by the local anesthetic .easy, intermediate, or impossible. On the second day post-intervention, the patients were interviewed retrospectively by a blinded study doctor. Herein, patients were asked, if they felt any pain at all at the scene of accident, immediately after specific analgesic procedure, during the prehospital medical intervention as well as at rest on the day of accident, on the first and on the second day after the accident. In those patients with pain the average pain intensity was recorded for given events and time points. In the ward of the trauma surgery departement of the University Medical Center of Goettingen patients were given ibuprofen  according to standardized protocol. Oxycodone/naloxone  was prescribed if further analgesia was necessary.Vital parameters were regularly recorded. Patient characteristics including location (upper/lower limb) and type of injury (dislocation/closed fracture/open fracture) were documented as well as intensity of pain at arrival of the trial EP. Pain scores were recorded using a numerical rating scale (NRS 0 = no pain to 10 = worst pain imaginable) on first contact with the trauma patient by the trial EP. Intravenously administered analgesics were documented. After induction of the respective analgesic procedure, onset of action of PNB  or AS  was recorded. In cases in which reduction was required, technical performance of the maneuver was classified by the managing trial EP as Symptoms and signs of nerve damage of the affected extremity were elicited. Patient satisfaction with specific analgesic procedure  was recorded and the patients were asked, if they would recommend the analgesic technique.The primary outcome was presence of pain [yes/no] during the prehospital medical intervention. Secondary outcomes were feasibility of reduction and associated pain scores during prehospital medical intervention, at the scene of accident, immediately after specific analgesic procedure and at rest on the whole day of accident, on the first and on the second day after the accident. Further secondary outcomes were complications  and patient satisfaction with the specific analgesic procedure. Based on prior observations, a power analysis revealed that 12 patients in each group would be sufficient to permit in 95% a painless prehospital intervention in the PNB-group compared to 45% in the AS-group . The data were analyzed with the statistics program StatSoft® . Continuous data were tested for normal distribution with the Kolmogorov-Smirnov test. Normally distributed data were described with mean and standard deviation, and others with median and interquartile range (IQR). Categorical data were given as percentages. Normally distributed data were compared with the two-tailed Student t-test for independent samples, and non-normal data with Mann-Whitney U-test. Categorical data were compared with two-tailed Fisher's exact test and with two-tailed Pearson's Chi-square test. A p-value <0.05 was defined as statistically significant.Thirty patients were screened for eligibility and were randomized. All 30 prehospital emergency patients were included in the study. Eighteen patients were allocated to the study group (PNB) and 12 patients were allocated to the control group (AS) .Both groups exhibited similar anthropometric data and no significant difference was noted with respect to the American Society of Anesthesiology (ASA) classification .Vital parameters such as heart rate and peripheral saturation, which were documented before the analgesic intervention, were found to be evenly distributed. A difference was noted in the initially recorded blood pressure . Further2<90%) occurred in two AS-patients, but saturation quickly increased after increasing the oxygen flow rate.After the analgesic procedure, no significant difference was observed in the hemodynamic parameters . HoweverThe following PNBs were used in patients with upper extremity injuries: interscalene brachial plexus block (n = 1), infraclavicular brachial plexus block (n = 1). The distribution of the PNBs in patients with lower extremity injuries were: combination of femoral nerve block and sciatic nerve block (n = 12), single femoral nerve block (n = 4). In the PNB-group systemic analgesia was already administered by a previous acting EP in 16 patients (88.9%), while the trial EP was additionally demanded. easy by the trial EP in 80.0% [12/15] of the PNB-patients and as impossible in the remaining 20.0% [3/15] of patients. On the contrary, only 22.2% [2/9] of reduction maneuvers were described as easy, and another 22.2% [2/9] as intermediate, while 55.6% [5/9] of maneuvers were assessed as impossible (p = 0.01).Twenty-four patients presented with dislocation injuries; prehospital reduction was performed under PNB in 15 patients (83.3%) and under AS in 9 patients . No difference was seen in the onset of action of the analgesic technique between the two groups . The feasibility of prehospital reduction maneuver was described as During this prehospital medical intervention, only 5.6% of the PNB-patients 1/18] in contrast to 58.3% of the AS-patients [7/12] experienced pain (p<0.01), and the recorded pain score was less in the PNB-group  1.2±0.6 in the PNB-group and 2.0±1.5 in the AS-group (p = 0.06). All patients of the PNB-group and only 50.0% of the AS-group would recommend their respective technique (p<0.01).In this study, we compared the effects of prehospitally administered PNB to AS alone in trauma patients who presented with an isolated extremity injury. We investigated pain intensity during and up to two days after an emergency procedure at the scene of accident, and the effects of the respective analgesic approach on the feasibility of a prehospital reduction of dislocation injuries of the extremities. Our results suggest that ultrasound-guided PNB can be used expediently in the prehospital emergency management of extremity injuries. Patients who received a PNB not only experienced less pain but the necessary reduction procedures were more easily performed than in patients who received AS alone.Pain is one of the leading complaints of trauma patients . NeverthPNB has long been performed with success in the military trauma patients . DespiteMcRae and co-workers  comparedSuccessful reduction requires adequate analgesia and muscle relaxation. With regard to the outcome of the dislocated extremity injuries, it is especially interesting how much relief a PNB affords the undertaking of a necessary reduction. Only two previous studies have compared the success rate of shoulder reduction in the emergency department following PNB or AS, and reported equivalent good results ,25. BothThere are still major concerns among clinicians with regard to PNB in patients with extremity fractures explained by their worries that PNP may mask the early symptom of compartment syndrome “pain” and miss timely diagnosis ,2,9,10. There are some limitations of this study. In addition to the relatively small trial, the number of subjects in the samples were not equivalent. There were different types of medical interventions required for the patients of each group. Due to already administered AS by primary acting EPs a standardized intravenous AS could not be performed. The nerve block procedure may trigger a placebo-effect in the study group, which only can be excluded by perineural injection of saline solution in the control group. Because of aggravated circumstances in the prehospital settings the PNB-performing EPs have to exhibit a high education level in ultrasound-guided regional anesthesia. Furthermore, prehospital care in some countries (e.g. the United States of America) is provided by paramedics, who are unlikely to acquire the expertise required for ultrasound-guided PNB in the field.In conclusion, this study demonstrates for the first time that prehospital ultrasound-guided PNB can be conducted with high success. PNBs could be extended to almost all patterns of injuries to the extremities. In addition to several investigations on performance of PNB in the emergency departments or prehospital settings, we could show that PNBs significantly reduce pain intensity and severity in trauma patients. Particularly, by using ultrasound-guided PNB, prehospital reduction-feasibility of dislocated extremity injuries, and presumably the success rate of reduction, can be improved.S1 File(PDF)Click here for additional data file.S2 File(PDF)Click here for additional data file.S3 File(DOC)Click here for additional data file.S1 Table(XLSX)Click here for additional data file.


To evaluate the depression and anxiety status and related risk factors in patients with lumbar disc herniation, and help spine surgeons better identify those patients who need psychological care.A cross-sectional study was performed on patients with lumbar disc herniation treated in our hospital between October 2015 and August 2018. Visual analog scale and Oswestry disability index were used to assess pain intensity and lumbar function, and Zung self-rating depression and anxiety scale were employed to evaluate the depression and anxiety status of the patients, and the demographic and clinical data including age, gender, marital status, occupation type, employment status, education level, surgery history, herniation type, disease duration, and insurance status were collected for analysis.In the current study, 165 patients were enrolled based on the inclusion and exclusion criteria. In multivariate logistic regression analysis, gender (p=0.03), pain intensity (p=0.01), self-rating anxiety scale (SAS) (p=0.00), and disease duration (p=0.001) were identified as independent risk factors for depression status, and pain intensity (p=0.02), disease duration (p=0.002) and SDS  (p=0.003) were independent risk factors for anxiety status in patients with lumbar disc herniation. There was a significant correlation between Zung self-rating depression and anxiety scale in patients with lumbar disc herniation (p<0.05).Psychological intervention is critical for patients with lumbar disc herniation, especially for those female patients with severe pain and longer disease duration. Low back pain (LBP), as one of the most common diseases, is being experienced by about 70% of people at some point in their life.Currently, some studies have been conducted to assess the psychological status and determine the associated risk factors for abnormal psychology in LDH patients. KimAccordingly, we conducted this cross-sectional study on LDH patients treated in our hospital between October 2015 and August 2018’. The aim of this study was to evaluate the depression and anxiety status and related risk factors in LDH patients. We believe this study may help spine surgeons better understand the psychological status, and identify those patients who need psychological care.This cross-sectional study was performed on LDH patients treated in our hospital between October 2015 and August 2018. The diagnosis of LDH was confirmed by clinical symptoms and computed tomography or magnetic resonance imaging examination. The inclusion criteria were: (1) patients diagnosed with LDH treated surgically or conservatively, and (2) patients who agreed to participate the study and signed informed consents. To facilitate the data analysis, only patients with one level herniation were included. Those patients with other pain syndromes, neurological disease, psychiatric disease as well as serious chronic disease such as cardiovascular disease, rheumatoid arthritis and epilepsy, which may interfere with the final outcomes, were excluded. The demographic and clinical data including age, gender, marital status, occupation type, employment status, education level, surgery history, herniation type, disease duration, and insurance status were collected for analysis. This study was approved by the ethics committee of our hospital.11In this study, Visual analog scale (VAS) and Oswestry disability index (ODI) were used to assess the pain intensity and lumbar function in the enrolled patients. During the assessment of VAS, the patients recorded their pain on a sheet of 10-cm long paper divided by 10 lines. In VAS, pain is rated on a scale from 0 to10, in which 0 indicates no pain, but 10 indicates the severest pain which the patients can’t stand.Statistical analysis was carried out using SPSS 21.0 . The measurement data were compared by analysis of variance, and enumeration data by Chi square test. Multivariate logistic regression analysis was performed to determine the correlation between the demographic and clinical variables and depression or anxiety status. A p value less than 0.05 was regarded as statistical significance.In the current study, 165 patients were enrolled based on the inclusion and exclusion criteria. Among 165 patients, 116 were male and 49 were female, with an age ranging from 28 to 59 years old. The basic demographic, clinical and socioeconomic characteristics of the enrolled patients show in In terms of depression status, 55 patients were included in depression group and 110 in non-depression group according to SDS scores, the rate of depression was 33.3%. There were significant differences in age (p=0.01), gender (p=0.029), surgery history (p=0.007), pain intensity(p=0.01), ODI scores (p=0.006) and disease duration(p=0.002), but no significant differences in occupation type (p=0.46), employment status(p=0.93), marital status(p=0.091), education level(p=0.609), herniation type(p=0.122), and insurance status(p=0.58) between the two groups . In multAs to anxiety status, 62 patients were included in anxiety group and 103 in non-anxiety group based on SAS scores, the rate of anxiety was 37.6%. There were significant differences in marital status(p=0.012), surgery history (p=0.046), pain intensity(p=0.0003), ODI scores (p=0.01) and disease duration(p=0.015), but no significant differences in age (p=0.177), gender (p=0.07), occupation type (p=0.575), employment status(p=0.172), education level(p=0.144), herniation type(p=0.053), and insurance status(p=0.39) between the two groups . In multIn addition, the mean SDS score in anxiety group and non-anxiety group was 65.7±9.5 and 40.8±8.1, respectively. There was significant difference (p<0.05) between the two groups . SimilarIn this study, we found that depression and anxiety in the enrolled patients was 33.3% and 37.6%, respectively, indicating the rate of LDH patients with abnormal psychological conditions was high, and these patients should be given more psychological care. Also, we confirmed female sex, higher SAS scores, higher pain intensity and longer disease duration were independent risk factors for depression, and higher pain intensity, longer disease duration and higher SDS scores were independent risk factors for anxiety in LDH patients, which may facilitate physicians better identify the patients with poor psychological conditions.As to the risk factors for depression, in a study of 91 patients with LDH, Chen and colleagues concluded that female sex, SAS and VAS scores were independent risk factors,In terms of the risk factors for anxiety, we found that pain intensity, disease duration and SDS scores were risk factors. Chen’s study also advocated that SDS scores and disease duration were independent risk factors, but pain intensity wasn’t.Moreover, in this study we found there was a significant correlation between SAS and SDS scores, and depression and anxiety were risk factors for each other, they influenced each other and were reciprocal causation. At the same time, a study conducted by Edwards indicated that the symptoms of depression and anxiety were significant independent predictors of worse pain and function after controlling for relevant covariates.First, we confirmed some factors which were related to the depression or anxiety status in patients with LDH, but some other factors, such as bad lifestyle habits including tobacco use, physical inactivity and alcohol abuse, may also significantly affect the psychological conditions of patients, but these factors were not analyzed in the current study. Second, some socioeconomic factors, such as insurance and employment status, were not risk factors in the present study, but the influence of which on psychological status may be different in different areas or countries, as they are associated closely with socioeconomic conditions. Third, we studied the depression and anxiety status and related factors in this study, but some other abnormal psychology such as stubborn, hostility and somatization were not analyzed in this study, so the correlations between LDH and these abnormal psychological status as well as related risk factors are still unclear. Hence, more future studies need to be carried out to further clarify these issues.SJT conceived, designed and did statistical analysis & editing of manuscript.WZM, YS and CCZ did data collection and manuscript writing.SJT and WZM did review and final approval of manuscript.


Prehospital acute pain is a frequent symptom that is often inadequately managed. The concerns of opioid induced side effects are well-founded. To ensure patient safety, ambulance personnel are therefore provided with treatment protocols with dosing restrictions, however, with the concomitant risk of insufficient pain treatment of the patients. The aim of this study was to investigate the impact of a liberal intravenous fentanyl treatment protocol on efficacy and safety measures.< 3) at hospital arrival. Secondary outcomes included abnormal vital parameters as proxy measures of safety. A multi-level mixed effect logistic regression model was applied.A two-armed, cluster-randomised trial was conducted in the Central Denmark Region over a 1-year period. Ambulance stations (stratified according to size) were randomised to follow either a liberal treatment protocol (3 μg/kg) or a standard treatment protocol (2 μg/kg). The primary outcome was the proportion of patients with sufficient pan relief  P = 0.0001]. The number of patient with sufficient pain relief at hospital arrival was higher in the liberal treatment group than the standard treatment group . The relative decrease in NRS scores during transport was less evident [adjusted odds ratio 1.18 (95% CI 0.95–1.48)]. The occurrences of abnormal vital parameters were similar in both groups.In total, 5278 patients were included. Ambulance personnel following the liberal protocol administered higher doses of fentanyl [117.7 μg (95% CI 116.7–118.6)] than ambulance personnel following the standard protocol [111.5 μg (95% CI 110.7–112.4), Liberalising an intravenous fentanyl treatment protocol applied by ambulance personnel slightly increased the number of patients with sufficient pain relief at hospital arrival without compromising patient safety. Future efforts of training ambulance personnel are needed to further improve protocol adherence and quality of treatment.NCT02914678). Date of registration: 26th September, 2016.ClinicalTrials.gov ( Efficient analgesic treatment is fundamental to ensure patient comfort and to facilitate transport from incident site to hospital , 2. NotwIntravenous opioids are the mainstay in the rapid relief of severe acute pain, but side effects, such as sedation and respiratory depression, cannot be overlooked –18. Due The aim of this study was therefore to explore the impact of liberalising a standard treatment protocol from a maximum dose of 2 μg/kg to an allowed maximum dose of 3 μg/kg on the intensity of pain at hospital arrival. We hypothesised that a larger proportion of patients would experience sufficient pain relief with the liberal treatment protocol. In addition, we examined the frequency of abnormal vital parameters.This study was a two-armed, open-label, cluster-randomised controlled trial comparing the impact of a standard and a liberal fentanyl treatment protocol on efficacy and safety parameters.The trial was conducted in the Central Denmark Region over a one-year period from 1st October 2016 to 30th September 2017. Sixty-six ambulances from 36 ambulance stations provide the emergency medical service for the 1,300,000 inhabitants of Central Denmark Region, corresponding to 22% of the Danish population. The Region covers both rural and urban areas .All patient care recordings were either automatically  or manually ), respiratory rate) entered into an electronic touchscreen-based prehospital medical record by EMTs/PMs. Assessment of pain intensity , 0–10) was required according to protocol from before initiation of fentanyl treatment and every 5–10 min until hospital arrival. Furthermore, each registration was logged with the exact date and time combined with the title (EMT/PM/physician/nurse) and unique user identification number of the treating healthcare provider.The sample included all patients treated with intravenous fentanyl by EMTs or PMs. We did not consider patients for analysis if: 1) prehospital physicians were dispatched to the scene and/or were providers of treatment, 2) they were treated by personnel other than EMTs/PMs (nurses), 3) they had unregistered personal civil registration numbers and 4) the same patient appeared more than once in the inclusion period, in which only the first case was included. Patients with pain scores registered at both baseline and hospital arrival were considered for the analysis of efficacy, and all patients were considered for the analysis of safety.n = 8): < 70 transports), level 2 (n = 12): 70–199 transports, level 3 (n = 8): 200–399 transports, level 4 (n = 4): 400–899 transports, and level 5 (n = 4): ≥ 900 transports). Each type of treatment protocol was then randomly allocated in a 1:1 ratio within each of the 5 levels. Randomisation of ambulance stations was carried out by an impartial statistician at Aarhus University using STATA version 13.1 .Randomisation was performed at the ambulance station level with allocation to either the standard treatment protocol for intravenous fentanyl (max 2 μg/kg) or the liberal treatment protocol (max 3 μg/kg). The 36 ambulance stations were stratified into 5 levels based on the average number of transports per month . Means with 95% confidence intervals (CI) are included for continuous parametric variables. Continuous nonparametric data are provided as medians with interquartile ranges (IQR). Categorical and binomial data are presented as numbers and proportions with 95% CIs. A chi square test, unpaired or paired students t-test or Mann-Whitney U-test is used for descriptive statistics when appropriate. A multi-level mixed effect logistic regression model was fitted on binary outcomes in order to account for the potential correlation between patients within the same cluster (i.e. patients nested within EMT/PM and EMTs/PMs nested within ambulance station). The highest cluster level was defined as 1) ambulance station, followed by 2) EMT/PM and 3) the patient. For the adjusted estimates of safety outcomes, the model could not be fitted without removing the highest level of clustering. The results are presented as unadjusted and adjusted odds ratios (OR) with 95% CIs and patients treated with the standard protocol as reference.The covariates considered in the multivariate statistical analyses are based on the existing literature and clinical experience: age (restricted cubic splines) , 28–32, To handle potential differences in baseline pain intensity –32, 39 bP values < 0.05 were considered statistically significant.We used a previous study from the same prehospital setting and with a similar patient population treated with intravenous fentanyl by EMTs/PMs as reference, in which 42% achieved NRS ≤ 3 at hospital arrival . With a ClinicalTrials.gov (NCT02914678).The study was approved by the Danish Data Protection Agency (no. 1-16-02-294-16) and the National Board of Health (no. 3-3013-2002/1). The local ethics committee was consulted, and the study was approved with a waiver of patient consent. The trial was registered at P = 0.001]  vs. 111.5 μg (95% CI 110.7–112.4), P = 0.09]. Higher doses were given in the liberal treatment group for the patients not having sufficient pain relief (NRS > 3) at hospital arrival than in the standard treatment group [136.3 μg (95% CI 131.9–140.8) vs. 126.9 μg (95% CI 123.0–130.7) (P = 0.001)] (Table no difference existed between the two groups compared . Characteristics of patients with missing pain scores are presented in Table A considerable number of patients in both groups had missing pain scores [liberal: 22.7 (95% CI 21.1–24.3) vs. standard: 27.8 (95% CI 26.1–29.5), In this large two-armed, cluster-randomised controlled trial we found that patients treated with a liberal protocol were more likely to have sufficient pain relief at hospital arrival than patients treated with a standard treatment protocol. It can be argued that the difference was small, and the question remains why more than half the patients had insufficient pain relief, even with a liberalised protocol. The explanation may be found in the conservative doses of administered fentanyl, which again may reflect concerns of malingering patients, apprehension of inducing side effects, and worries about blurring symptoms and further diagnostics , 43. TheP = 0.028). In terms of side effects, a higher frequency of drowsiness in the patients treated with the rapid regiment was observed [Few other randomized controlled trials on prehospital analgesia for adults have been conducted including small samples ranging from 24 to 312 patients. Similar to our study, two randomised controlled trials have investigated the impact of increasing the opioid doses on analgesic efficacy and safety. Woollard et al. investigated 172 prehospital patients with diverse aetiologies of pain. The researchers found that a rapid administration regiment leading to higher cumulative doses (14.8 mg) of intravenous nalbuphine (a semi-synthetic opioid) was more effective than a cautious regiment 10.7 mg) with a lower dose  and this may have introduced bias. Depending on study design and patient selection, the proportion of patients with missing pain data in other prehospital studies ranges from 15% , 25–35% Second, the implementation of the liberal protocol was left to the discretion of the enrolled ambulance station leaders. This approach thus reflects the effect of protocol changes when implemented in real-life settings but may also partly explain the relatively small difference observed between the groups.Third, our study was probably not powered to detect small differences on abnormal vital parameters as proxies of adverse effects, as these events are infrequent, and therefore a risk of type II errors exists. As the most conservative example, 7093 patients in each arm would have been required in order to find an occurrence of hypotension of 3% among patients treated under the standard protocol compared to 4% among patients treated under the liberal treatment protocol.Last, the occurrence of fentanyl side effects can be difficult to quantify precisely with discrete measures. Exemplified by respiratory depression, hypoxemia may very well be correlated with oxygenation as measured by pulse oximetry when patients are breathing at atmosphere oxygen levels. However, it will be affected by factors such as supplemental oxygen therapy or peripheral vasoconstriction . The preLiberalising an intravenous fentanyl treatment protocol applied by EMTs/PMs resulted in slightly more patients having sufficient pain relief at hospital arrival compared to patients treated under a standard treatment protocol. Fentanyl doses were conservatively administered in both groups and the high overall proportion of patients with insufficient pain relief suggests that more should be done to ensure protocol adherence. No differences in the occurrence of abnormal vital parameters were observed between the two groups, suggesting that future efforts in optimising intravenous fentanyl protocols for non-physician staff can be made safely under ongoing evaluation and monitoring of the patients.


Uses of simple analgesics were found insufficient to manage pain after thyroid surgery. We hypothesized that using bilateral superficial cervical plexus block (BSCPB) might influence the pattern of immediate postoperative pain and analgesic consumption. The general objective of the study was to assess the analgesic efficacy of bilateral superficial plexus block for thyroid surgery under general anesthesia.A total of 74 willing patients involved. Half of them had received BSCPB with 10 ml of 0.25% bupivacaine just before induction and the remaining half did not. Postoperatively, patients were assessed at immediate, 2nd, 6th, 12th and 24th h. At all endpoints, NRS-11 scores for pain were significantly lower in the block group. The time to first analgesic requirement was significantly longer 132.3 ± 71.5 min vs 71.4 ± 60.0 min, p = 0.009. Opioid and total analgesic consumption were reduced by BSCPB in the first 24 postoperative hours. There was low but non-significant rate of PONV in the block group. No clinically important adverse event was noted related to BSCPB.Trial registration The study was registered in Pan African Clinical Trial Registry on 13/01/2020 and the registration number is PACTR202001579588451. Retrospectively registered. Thyroid disease is one of the major public health problems in Ethiopia –3. HenceAcute pain is one of the commonest complaints in the postoperative period which has serious adverse cardiovascular, pulmonary, metabolic and psychological outcomes –8. Pain Simple analgesics such as paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) were found insufficient to manage pain after thyroidectomy . BilaterWe hypothesized that using BSCPB may influence the pattern of immediate postoperative pain and analgesic consumption. The general objective of the study was to assess the analgesic efficacy of bilateral superficial plexus block for thyroid surgery under general anesthesia.A prospective cohort study was conducted in University of Gondar Hospital (UoGH), Northwest Ethiopia from February to June 2016. The study was registered in Pan African Clinical Trial Registry (PACTR202001579588451). All adult (18+) ASA I and II patients who undergone thyroidectomy at the hospital during the study period were included in the study. Patients who have refused to participate, allergic history for local anesthetics, retro-sternal goiter, altered anatomical landmarks, coagulation abnormality and other contraindications for the block were excluded.Pain severity, time to first analgesic request and total 24 h analgesics consumption were outcome variables. Socio-demographic, ASA class, size and type of thyroid mass and duration of anesthesia and surgery were some of the independent variables.The sample size was determined by postoperative morphine requirement in the first 24 h. BSCPB with 0.25% of bupivacaine reduced morphine requirement (mg/Kg) in the first 24 postoperative hours by nearly 55% median in mg/Kg  . CalculaTwo data collectors were assigned. One for pre- and intraoperative time, and another for postoperative time to facilitate blinding. Assessments were done at postoperatively in the recovery room; immediately after arrival, 2nd, 6th, 12th and 24th h. Postoperative pain was assessed using NRS-11. First analgesia request time, and total analgesia consumption within 24 h were documented. Data was checked and analyzed by SPSS-20 (IBM Corporation). Normality was checked by Shapiro–Wilk test. An independent t-test was performed to compare time to first analgesic request. Mann–Whitney U test was used to analyze repeated NRS-11 scores and total postoperative analgesic consumption. Normally distributed data was presented in mean ± SD whereas non-normally distributed data was presented as median (IQR). A p-value < 0.05 was considered as statistically significant.A total of 74 patients (34 in each group) were involved. The demographic, anthropometric and clinical characteristics of participants were found comparable between the groups Table . Sub-totAt all endpoints, pain scores were significantly lower in the block group. Furthermore, the first analgesic request time was significantly longer in the block group than the non-block group Table . The totWe found statistically significant reduction in mean NRS-11 scores at all end-points in the block group. The time to first analgesic requirement was nearly doubled in the block group . Multiple studies have investigated the effectiveness of BSCPB in thyroid surgery and reported that it was effective in minimizing pain scores, opioid and total analgesic consumption and prolonging analgesia duration , 22. A mIn-contrast, some studies denied the effectiveness of BSCPB. The block had failed to demonstrate reduction in pain scores and opioid consumption. But longer time for first analgesic request was observed. They explained the result by pain arising from deeper and muscular structures, pain from positioning and wound drainages . DespiteIn this study, all blocks were done by landmark technique by subcutaneous deposition of local anesthetic along the posterior borders of sternocleidomastoid muscles on both sides of the neck. In a recent Egyptian study that compared landmark and ultrasound-guided techniques found no difference in effectiveness and safety . HoweverPerforming regional nerve blocks and administration of multi-modal analgesics prior to surgical incision are helpful in reducing intra- and postoperative opioid consumption, primary hyperalgesia, central sensitization and chronic pain , 23, 27.Wound infiltration is effective choice of analgesia after thyroid surgery. But compared to BSCPB, the later was found more effective. Time to first analgesia were 162 ± 124 min vs 544 ± 320 min vs 860 ± 59 min in control, wound infiltration and BSCPB groups respectively; p < 0.001 . This anThe incidences of postoperative nausea and vomiting (PONV) after thyroidectomy ranges from 21.7% up to 84% , 33. We We have concluded that BSCPB has significantly reduced pain scores, opioid and total analgesic consumption and prolong the time to first analgesic requirement. We recommend that BSCPB is simple and can be used effectively and safely for pain management after thyroid surgery as a part of multi-modal analgesia in the first 24 postoperative hours.As a cohort study, the confounders might not be adequately controlled. We also have not studied the impact of the block on intraoperative analgesic and anesthetic requirements.


To describe characteristics and activity limitations of new patients with musculoskeletal conditions presenting to the World Spine Care (WSC) clinic located in the underserved community of Moca, Dominican Republic.We conducted a prospective case series of consecutive adults between October 12 and December 5, 2015. A survey of valid and reliable measures including: Body pain diagram, Wong-Baker FACES® pain rating scale, Spine Functional Index (SFI), Lower Limb Functional Index (LLFI), Upper Limb Functional Index (ULFI) and the 12-item Short Form Health Survey (SF-12v2) was administered to collect socio-demographics, expectation of recovery, comorbidities, and self-reported health status data.Forty-two patients  were included. The most common primary complaint was lower back pain  and 57% (24/42) of individuals reported pain that interfered with their ability to function and engage in daily activities. Half of the patients presented with two complaints. Complaints were similar between genders. Most patients  reported chronic pain (> 6 months) and 97% (41/42) reported believing that they would recover. Twenty-one percent (9/42) self-reported being diagnosed with depression and/or anxiety at some point in their life. In addition, most  individuals reported below average physical and mental health related quality of life.This study is the first to describe characteristics of patients seeking care at the WSC clinic in Moca, Dominican Republic. Most patients attending the clinic suffer from persistent spine complaints that interfere with their ability to function and engage in daily activities. Nevertheless, the patients have positive expectations of recovery. Musculoskeletal conditions such as low back and neck pain are leading causes of disability in developing nations –3. In thWith a population of 10.4 million  the DomiThe burden of disease attributable to musculoskeletal conditions has increased by 60% from 1990 to 2010 in developing nations globally . In the World Spine Care (WSC) is a non-profit organization with a mission to improve the lives of individuals in underserved communities through sustainable, integrated evidence-based spine care. World Spine Care opened in Moca, Dominican Republic in November 2014 . The MocLittle is known about the health care utilization for musculoskeletal conditions in the Dominican Republic. Therefore, the objective of our study was to describe the socio-demographic characteristics, health status, functional limitations and self-reported quality of life of adults presenting to a World Spine Care clinic located in Moca, Dominican Republic.We conducted a prospective case series of consecutive new patients presenting to the WSC clinic in Moca, Dominican Republic between October and December, 2015. A prospective case series is a small exploratory study that has been approved by an ethics board, in which participants enrolled provide informed consent to participate prior to data collection. The primary investigator was responsible for participant recruitment, data collection and obtaining consent. We defined cases as adults presenting to the WSC clinic in Moca for an initial assessment. To be included, cases had to be at least 18 years of age and fluent in Spanish or English. Participation in the study was voluntary; no compensation was provided for participation. All participants provided written informed consent and all information was kept confidential and anonymous. Participants were recruited between October 12, 2015 and December 5, 2015.WSC initial intake forms: Used to collect demographic characteristics, socioeconomic status, expectation of recovery  .r = 0.90; 95% CI = 0.86 to 0.93) and inter-rater reliability (ICC = 0.93) [Wong-Baker FACES® pain rating scale: Used to measure self-perceived pain intensity. The measure shows a series of 6 faces that depict pain sensation from “no hurt” to “hurts worst”. The measure has shown adequate agreement with Visual Analogue Scale ( = 0.93) –25. Apprr = 0.85–0.9) and reliable (ICC = 0.93–0.96) in both the English and Spanish languages [Functional outcome measures : Used to measure self-perceived functional ability. The specific functional index measures are a single page 25-items with a three-point Likert scale. A higher total score represents a higher level of functional disability. All items are summed for a maximum total score of 25. A percentage score  can be calculated and a lower percentage represents a higher level of functional disability. The recall period is within the last few days. These measures have been shown to be valid (anguages –31. If ar = 0.95–0.96) and reliable (test-retest) (α = 0.75–0.82) measure that has been used widely to assess the impact of musculoskeletal diseases in various populations as well as in the Dominican Republic [12-item Short Form Health Survey (SF-12v2): We used the SF-12v2 to measure of health-related quality of life. Scores range from 0 to 100, with a higher score indicating better self-perceived health. The acute (1-week) recall SF-12v2 was used. Physical Component Summary (PCS) and Mental Component Summary (MCS) component scores were calculated. The SF-12v2 is a valid (correlated to the SF-36)  and Consejo Nacional de Bioetica en Salud (CONABIOS) in the Dominican Republic .Forty-three patients presented to the clinic between October 12, 2015 and December 5, 2015. No patients refused to participate but one participant was excluded because of age (< 18 years old). The final sample included 42 participants. Twenty-six participants (62%) completed the questionnaire with assistance from a clinical assistant, the primary investigator and/or a family member. All of the surveys were completed in the Spanish language.n = 45 years; SD + 16.6). Fifty-five percent (23/42) were women; most participants were married  and 45% (19/42) had post-secondary education (university or college). Ninety-three percent (39/42) were able to read a newspaper.The age of participants ranged from 20 to 77 years old (meaAll participants reported to be working in paid or unpaid work and 62% (26/42) of those described their work as physically demanding. Common occupations included housework 21%; 9/42) office work  and working in the service industry  and retirees   previously consulted a health care professional for their complaints. Five percent of participants (2/42) were current smokers and 19% (8/42) had smoked in the past. Fifty-seven percent (24/42) reported that they currently consume alcohol. This was equal between genders. Twenty-one percent (4/19) of males engaged in sport regularly while only 4% (1/23) of females reported engaging in sport on a regular basis (Table + 2.78). Thirty-three percent of participants (14/42) reported worsening of their symptoms since onset, 36% (15/42) reported their pain was the “same” and 31% (13/42) reported their pain had improved since its onset. Most participants  reported the duration of pain of their primary complaint had been present for more than a year. Nineteen percent (8/42) of participants reported current complaints due to a work-related injury. Most participants  reported pain that interfered with their daily activities. Sixty-four percent (27/42) of participants self-reported being diagnosed with chronic pain (> 6 months in duration) and chronic pain was more common in females  than males .Half of the participants 21/42) reported two musculoskeletal complaints and 7% (3/42) presented with three complaints. Most primary complaints were lower back pain  upper back pain , neck pain  and shoulder pain  (Table 1/42 repoNineteen percent of participants (8/42) reported that their current pain prevented them from engaging in sport; this was equal between genders. Participants reported spending the majority of their day sitting 33%; 14/42), followed by engaging in manual labour , walking  and standing . Seven percent of participants (3/42) reported that their current pain prevented them from walking  for spinal complaints 12.6/25 (SD = + 8.4) for upper limb complaints and 12.7/25 (SD + 6.4), for lower limb complaints. Functional index measures were also stratified based on rank of complaint. These measures indicated that individuals had a moderate (50%) level of functional disability that impacted their daily lives  in comparison to males with a mean of 42.7 (SD + 11.8). The mean mental component score was 46.8 (SD + 11.0), which was similar between genders. One in five participants  self-reported having been diagnosed with depression and/or anxiety at some point in their lives.Participants perceived their self-reported physical and mental health related quality of life to be lower than the US adult norm of 50. The mean physical component score (PCS) for females was 38.4  reported that they expected to recover from their current health conditions , low back pain (#2), anxiety (#4), neck pain (#8) and other musculoskeletal conditions (#10) were within the top 10 causes of years lived with disability . Our stuIn 2009 a survey conducted in three rural underserved villages in the Dominican Republic found that hypertension 36%), diabetes (15%) and asthma (14%) were common in these populations [%, diabetIn a previous study conducted in the Monti Cristi region of the Dominican Republic, 18.6% of individuals reported experiencing general pain . In addition, general pain was the most frequently reported symptom . The curThe findings from these two prior studies , 37 combp < 0.1) [Our study agrees with a previous study which assessed musculoskeletal disorders in the medically underserved regions of Peru, Ecuador, Argentina and Vietnam in which participants were sampled during brief medical outreach mission trips. In those countries studied, the prevalence of musculoskeletal symptoms was high. The South American patients reported experiencing acute pain most commonly in the lower back (44.7%) followed by the upper back (46.6%). The Vietnamese patients reported experiencing acute pain most commonly in the knees (44.7%) followed by the upper back (35.0%). In addition, for patients in both samples, acute pain was associated with chronic pain in the same location for all body parts (p < 0.1) . Our stuThe 2017 Global Burdens of Disease Study identified that in Canada low back pain (#1), diabetes (#3), depressive disorders (#4), other musculoskeletal conditions (#6) and neck pain (#10) were within the top 10 causes of years lived with disability . The finOur study had strengths. First, a consecutive sample of participants were recruited. Second, no participants refused to participate in the study. Third, the primary investigator reviewed all questionnaire for completeness. Our study also has limitations. First, the psychometric properties of our questionnaire were not previously tested for use in our population. However, the functional outcome measures have appropriate reliability and validity in the Spanish language , 29, 31.Our study highlights the challenges of conducting research in an emerging nation. Specifically, the process involved in obtaining approval from the Consejo Nacional de Bioetica en Salud (CONABIOS) Ethics Review Board was complex and lengthy. We needed to collaborate with an intermediary representative from the Dominican Republic who communicated with the Ministry of Health Board on behalf of the research team. This process led to significant delays in initiating the research.The Dominican culture is different from the culture of western countries. Specifically, participants are not accustomed to the lengthy questionnaires needed to conduct clinical research. This typically resulted in participants becoming fatigued with paperwork and requiring support to ensure appropriate completion. Moreover, the relaxed attitude towards schedules often had patients attending the clinic at the times that suited them without prior notifications. This is concerning because these factors can affect participant recruitment, and appropriate study completion timeframes.In future research, investigators should ensure that an appropriate time (6–9 months) is allocated to guarantee ethics approval. In addition, researchers should streamline paperwork, ensure all paperwork is organized, and can be completed and checked efficiently by research staff and patients. Individuals should be cognizant of the burden that extensive paperwork places on clinical support staff and patients and work with a dedicated clinical assistant. To optimize participant recruitment, data collection and study completion, future researchers should ensure that appropriate communication regarding travels dates, clinic hours and national holidays occurs between all involved organizations.Our study was the first to describe characteristics of patients seeking care at the WSC clinic in Moca, Dominican Republic. Our results suggest that most individuals seek care for primarily chronic spine complaints that interfere with their ability to function and engage in daily activities.


Background: Venipuncture is described by children as one of the most painful and frightening medical procedures.Objective: To evaluate the effectiveness of Virtual Reality (VR) as a distraction technique to help control pain in children and adolescents undergoing venipuncture.Methods: Using a within-subjects design, fifteen patients  suffering from oncological or hematological diseases received one venipuncture with “No VR” and one venipuncture with “Yes VR” on two separate days (treatment order randomized). “Time spent thinking about pain”, “Pain Unpleasantness”, “Worst pain” the quality of VR experience, fun during the venipuncture and nausea were measured.Results: During VR, patients reported significant reductions in “Time spent thinking about pain,” “Pain unpleasantness,” and “Worst pain”. Patients also reported significantly more fun during VR, and reported a “Strong sense of going inside the computer-generated world” during VR. No side effects were reported.Conclusion: VR can be considered an effective distraction technique for children and adolescents’ pain management during venipuncture. Moreover, VR may elicit positive emotions, more than traditional distraction techniques. This could help patients cope with venipuncture in a non-stressful manner. Additional research and development is needed. For many children, venipuncture is one of the most frightening aspects of visiting a hospital . ExperieTraditional distraction techniques  are some of the most common psychological strategies for the reduction of procedural pain and anticipatory anxiety during venipuncture .n = 32 studies) and only two VR distraction studies were included in Birnie et al’s Cochrane review.Virtual Reality (VR) is showing promise as an innovative distraction technique for pain management among children undergoing medical procedures ,c. VR reThere is a growing interest in using VR for distraction among children and adolescents; however, to date most clinical studies on VR analgesia have included burn patients during physical therapy  or durinThe aim of the present study was to investigate VR effectiveness as a distraction technique for pain management in children and adolescents with onco-hematological diseases undergoing venipuncture. Based on the From February 2014 to July 2016, patients attending the Service of Pediatric Oncology and Hematological Diseases of an Italian Children’s hospital participated. Children and adolescents who needed to undergo venipuncture twice in a year, for intravenous placement during chemotherapy, transfusions, magnetic resonance or blood analysis were recruited. Patients were selected according to the following criteria based on the existent literature : childreSD = 2.64, see Table Seventeen patients met the inclusion criteria. However, one of them withdrew because he decided to use his own distraction technique and another patient withdrew because he didn’t want to use VR during the second venipuncture (the reason was not indicated). A total of 15 patients  or the experimental condition (“Yes VR”) (treatment order randomized). Patients underwent the second venipuncture using the distraction technique not used the first time. The “No VR” control condition consisted of non-medical conversation by the nurse who performed the venipuncture (standard of care). In the “Yes VR” condition, patients interacted with VR during venipuncture. Before the nurse arrived, patients had 5 min to learn how to use the VR system. The helmet and the earphones included in the VR system were worn at the arrival of the nurse for the procedure and removed after the procedure. In both conditions, during the venipuncture, the patient, a nurse, the patient’s parent/caregiver and the psychologist researcher were present. After the procedure, the nurse left the room and patients completed the self-report questionnaire (pain ratings). No reward was given to patients for participating.At the end of the procedure, patients filled out a brief self-report questionnaire aimed to evaluate the pain, the quality of the VR experience, nausea and fun. Patients responded by giving a 0–10 score on a horizontal Visual Analogue Scale VAS; . Pain, e2, one of the most frequently employed VR environments, specifically designed to promote distraction from procedural pain  vs. during “Yes VR” mean = 1.33 (SD = 1.05), p < 0.05, Cohen’s d = 0.62, moderate effect size; “Pain unpleasantness” during “No VR” mean = 3.27 (SD = 3.43) vs. during “Yes VR” mean = 0.93 (SD = 1.16), p < 0.01, Cohen’s d = 0.70 moderate effect size; “Worst pain” during “No VR” mean = 3.60 (SD = 3.00) vs. during “Yes VR” mean = 2.00 (SD = 1.20), p < 0.05, Cohen’s d = 0.51, moderate effect size.As reported in Table SD = 1.79), corresponding to “strong sense of going inside the computer generated world”, and a mean realism of VR objects score of 6.80 (SD = 2.37), corresponding to “Moderately real.”Patients distracted by VR reported a mean presence score of 7.93 (SD = 3.58) vs. “Yes VR” mean = 8.80, SD = 1.42; t(14) = −6.60, p < 0.0001, Cohen’s d = 1.71, large effect size. No significant differences emerged for nausea levels between the two conditions (p > 0.05 NS): no patient reported nausea during the interaction with VR. During the “Yes VR” condition the mean of the total time of the procedure was 3.09 min (SD = 1.81) vs. 4.45 (SD = 3.50) during the “No VR” condition. The pattern of results showed the venipuncture took less time during VR vs. during No VR; however, the differences were not significant .Patients rated “fun” during the venipuncture as “mildly fun” during No VR, vs. “pretty fun” during VR. A significant difference for fun levels emerged between the two conditions: during “No VR” mean = 2.93  are recommended.Future studies may explore whether personality aspects of the child, such as catastrophizing, fear of pain, as well as parents’ anxiety, and patients’ memory for previous painful procedures  influencThis study contributes to a growing literature that supports the use of immersive VR distraction for pain control. The current study evaluated the effectiveness of VR to control pain  and to promote fun during venipuncture in pediatric patients with cancer and blood diseases. Younger patients suffering from chronic diseases , who spend much time in hospital and need several painful and stressful medical procedures, could particularly benefit from this distraction. In the future, VR systems could also let patients have social interaction  and the All authors listed have made a substantial, direct and intellectual contribution to the work, and approved it for publication.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.