Endometriosis (EM) is one of the most frequent differential diagnoses concerning chronic pelvic pain. Women under hormonal therapy (HT) often benefit from it but sometimes suffer a setback and develop acyclical pelvic pain. Due to the assumption that mechanisms of neurogenic inflammation are involved in the generation of chronic pelvic pain, we aimed to investigate the expression of sensory nerve markers in EM-associated nerve fibers of patients with/without HT.Laparoscopically excised peritoneal samples from 45 EM and 10 control women were immunohistochemically stained for: PGP9.5, Substance P (SP), NK1R, NGFp75, TRPV-1, and TrkA. Demographics and severity of pain were documented.EM patients showed a higher nerve fiber density (PGP9.5 and SP) and increased expression of NGFp75, TRPV1, TrkA, and NK1R in blood vessels and immune cells compared with controls. Patients with HT have cycle-dependent pelvic pain but suffer from acyclical pelvic pain. Interestingly, reducing NK1R expression in blood vessels under HT was observed. A correlation between dyspareunia severity and nerve fibers density and between NGFRp75 expression in blood vessels and cycle-dependent pelvic pain severity was observed.Patients under HT have no ovulation and no  bleeding, which correlate with inflammation and cyclical pain. However, acyclical pain seems to be due to peripheral sensitization once it is present under treatment. Neurotransmitters, like SP and their receptors, are involved in mechanisms of neurogenic inflammation, which are relevant for pain initiation. These findings indicate that in both groups (EM with/without HT), neurogenic inflammation is present and responsible for acyclical pain.The online version contains supplementary material available at 10.1007/s00404-023-07110-9. Characterized by the ectopic deposition and growth of endometrial-like tissues, endometriosis (EM) is an estrogen-dependent and inflammatory disorder . EM lesiDue to the duration of pain and dissemination of endometriotic lesions, the associated symptoms showed a wide variation including cyclic and acyclic lower abdominal pain, dysmenorrhoea, dyspareunia, dyschezia, dysuria and sub- or infertility. The pathogenesis of pain generation is very complex , 7, 8. RBecause the pathogenesis of EM is still unresolved, no causal treatment options are available. The primary treatment goals are to relieve pain and eliminate fertility issues in women who wish to conceive . HormonaThis prospective study enrolled 55 women. Forty-five EM patients, who underwent laparoscopy due to symptomatic EM with excision of endometriotic lesions, were included. The diagnosed EM was staged according to the revised classification of the American Society of Reproductive Medicine (rASRM) as I: minimal, II: mild, III: moderate, and IV: severe. In the analysis, two stages had been considered: mild (rASRM I and II) and severe (rASRM III and IV). Ten control samples were collected from women without EM, who had undergone laparoscopy for benign gynaecological presentations such as nonendometriosis associated with ovarian cysts, uterine fibroids, hydrosalpinx, pelvic pain, peritonealized tissue or the unfulfilled wish to have children.Patients were selected based on clinical intraoperative and subsequent histopathologic findings. All patients had been given a complete gynaecological examination. The severity of pain was documented using a standardized questionnaire with a visual analog scale (VAS). The pain intensity was determined with the help of a visual numerical analog scale . The women were divided into two groups based on the pain scale: moderate pain  and severe pain .The study was approved by the Institutional Review Board of the Charité University Medical Centre (Ethic vote EA4/036/12). All patients gave their consent.All the surgically excised lesions (EM patients) and healthy peritoneum (control samples) were immediately fixed in buffered formalin 4% for 12 h and thereafter embedded in paraffin. Two μm thickness sections were immunohistochemically stained with antibodies  against the nerve fibers markers: protein gene product 9.5 (PGP9.5), Substance P (SP); and nociceptive receptors: Neurokinin-1 Receptor (NK1R), Nerve Growth Factor Receptor p75 (NGFp75), Transient Receptor Potential Vanilloid 1 (TRPV-1), and Tropomyosin Receptor Kinase A (TrkA).Negative control sections were processed by omitting the specific primary antibody. A skin incision and a tissue section of peritoneal EM with large nerve incisions were used as the positive control. Staining was detected using an axiophot  microscope. Photomicrographs were taken at different magnifications (100 and 400) and were further processed using Adobe Photoshop .2.The density of PGP9.5 and SP-positive nerve fibers was assessed by counting the number of immunostained nerves proximal to the endometriotic lesions  and in the distal area at 1 mmThe “hotspot” method  was usedU, Wilcoxon, Kruskal–Wallis or Spearman correlation test). χ2 and Fisher’s exact tests were used for the qualitative variable. Statistically significance was assumed for p < 0.05.Statistical analysis was performed using Graphpad Prism 9 and non-parametric (Mann–Whitney-p = 0.0037).Demographic and clinical variables for the 55 women recruited for this study are summarized in Table The control group was a compost of ten patients, four of them received hormonal therapy. In one case, it was a pure progestin therapy, in two others, a combined progestin–estrogen therapy and in one other case, the product ingested could no longer be determined. Women in the control group were on average 32.1 (20–46) years old. No significant difference in age between the non-EM patients who took hormones (32.5) and the ones who did not take (31.8) was observed.Forty-two EM patients (95.5%) reported pelvic pain. One patient under hormonal treatment reported no pelvic pain. In two cases, no statement was made, these women were not taking any hormones. In the control group, six patients  stated to suffer from pelvic pain. Three (27.3%) denied suffering from this pain , and in two cases 18.2%), no information was given. All pain and patient characterization are summarized in Table 8.2%, no p = 0.0096) could be seen in the hormonal therapy and this pain. No CDPP was reported in seven EM patients . For 23 patients with EM (13 positives for hormone therapy), this information was missing. In the control group, three (27.3%) women reported CDPP. Two (18.2%) of them were on hormonal therapy. In seven cases (70%), this statement was missing.Of the 42 EM patients reporting pelvic pain, 15 (33.3%) communicate suffering from CDPP. Four of them were on hormonal therapy and eleven were not. A statistical difference  suffered on average from a pain level of 5.5 (2–9). No difference in the average pain severity was found between EM patients who were on hormonal treatment  and those who were not . In the control group (data from three patients), the severity of the CDPP was an average of 6 (4–9) and did not differ from the group of EM patients.Only ten (22.2%) EM patients describe suffering from CIAP with an average severity of 5.7 (2–8). Five EM patients under hormonal therapy report on average a CIAP of 5.2 (4–7) and for the five patients without hormonal therapy, a pain average of 6.3 (2–8). Two (20%) women under hormonal therapy from the control group also describe feeling this pain in severity 2 and 3.Dysmenorrhea or painful bleeding in cyclical modus of combined pills  was a symptom communicated from 39 (86.7%) EM patients, with 21 under hormonal therapy. Two patients , said do not suffer from this and the other four (8.9%) did not answer. In the control group, dysmenorrhea was expressed as a symptom for four women (40%), two of these being on hormonal therapy. Two patients  affirmed no painful bleeding in the cyclical modus of combined pills. This information was missing for four patients (40%) in the control group, two under the hormonal treatment.The severity of the dysmenorrhea or painful bleeding was informed for 21 EM patients (46.7%), 9 of them were under hormonal therapy. No statistical difference was found in the severity of the dysmenorrhea between EM patients who were under hormonal therapy  and those who were not . In the control group, two (20%) women reported the severity of this symptom. One patient who was taking hormones reported a pain level of 4 while the other, who was not taking hormones, reported a pain level of 3.Twenty-seven  EM patients reported dyspareunia. Four women  stated no pain during sexual intercourse. This information was not given for 14 EM patients . No information was given for six women  from the control group. Three patients  suffered from dyspareunia. Only one control patient (10%), who was under hormonal therapy, affirmed not to have this pain.EM patients reported an average degree of dyspareunia of 4.7 (1–10). Five patients, who were under hormonal therapy, reported a mean pain score of 5.6 (3–7). The other 11, who were not taking hormones, reported an average pain of 4.3 (1–10). Two patients from the control group  reported a pain score of 4 and 9.Dyschezia was indicated as a symptom in 16 (35.5%) patients with EM, 8 of them on hormonal therapy. Another 16 women (35.5%) stated that they did not have dyschezia. Of these, eight women took hormones. Thirteen EM patients (28.9%) did not answer this question. In the control group, one woman who received hormones suffered from dyschezia severity 4. Two women, one of them taking hormones, denied suffering from this condition (20%). In seven cases , the corresponding information was lacking in the questionnaire.A mean pain severity of 5.4 (3–8) concerning dyschezia was given in 16 EM patients (35.6%). Eight patients who were on hormone therapy estimated pain intensity to be a mean of 6.2 (3–8). However, the other eight women who did not receive hormones reported an average pain of 4.5 (3–6).Eight (17.8%) EM patients suffered from dysuria, four of them were on hormone therapy. In this group (only three patients answered this question), the average severity of the dysuria was given as 5.3 (5–6). In 21 cases , the dysuric pain was denied and in 16 cases (35.6%), the information was missing. One control patient affirmed suffering from dysuria with a severity of 2, another denied it. Both were under hormonal treatment. In eight cases (80%), this information was missing.All the results are presented as median, 25–75% percentile. Figure p = 0.0079) both in the view of nerve fibers per mm2 and in the hotspot image   but no difference in the density of SP-positive nerve fibers per mm2   compared to healthy peritoneum  and in the hotspot image view   and without hormonal intake (EM H−) compared with the control without treatment (Ctr H−) for PGP9.5 both in the nerve fibers per mmr = 0.728; p = 0.0029) and SP  nerve fibers density correlated with dyspareunia pain levels   , a difference that was not maintained when the EM patients with hormonal therapy were evaluated (p = 0.3312)    and nerve fibers per mm2   when compared with controls without treatment       and nerve fibers per mm2    Table .The majority of research into the mechanisms underlying pain in EM has focused on the endometriotic lesions with the estrogen-dependent cyclical release of pain mediators as the primary source of EM-associated pain , 15. ThiAlthough lesion-specific pain is undoubtedly essential for the induction of EM-associated pain, lesion removal does not provide pain relief in all cases . FurtherIn this study, we focused on peripheral sensitization of EM-associated nerve fibers: we investigated (i) the nerve fiber density of sensory nerve fibers in symptomatic EM patients, (ii) analyzed the expression of the SP and their receptor NK1R and (iii) the expression of nociceptive receptors and compared the findings between EM patients and controls and between patients using or not using hormonal treatment.2 and in hotspot image. EM patients also showed significantly more SP-positive nerve fibers in the hotspot view. Taken together, our data confirm the high innervation of the endometriotic lesion already seen by different groups [We demonstrated the presence of sensory nerve fibers in peritoneal endometriotic lesions in 45 women with confirmed symptomatic EM. The density of nerve fibers in peritoneal endometriotic lesions was much greater than in normal peritoneum in women with no EM, both in nerve fibers per mmt groups –20. Thest groups , 22. ThiNeurogenic inflammation is caused by releasing the neurotransmitters from sensitive nerve endings, through interaction with immune cells  and mighIncreased levels of neurotrophins such as NGF and their receptors NGFRp75 and TrkA are also seen in endometrial biopsies of women with EM , 25. ThePain severity was assessed to determine if there could exist a correlation between nerve fiber density, receptors expression and hormonal therapy. EM is associated with sexual pain, specifically, pain with deep penetration (dyspareunia). The etiology of dyspareunia in EM seems to be multifactorial , but a hIt has been shown that traditional hormone therapies that alleviate EM-associated pain, including progestogens and oral contraceptives, significantly reduced nerve fiber density in ectopic endometrium . What wePatients under hormonal therapy have no ovulation and no  bleeding, which are typically associated with inflammation and cyclical pain. However, acyclical pain seems to be due to peripheral sensitization once it is present under the treatment. Neurotransmitters, like SP and their receptors, are involved in mechanisms of neurogenic inflammation, which are relevant for pain initiation in women affected by this chronic disease. Taking together, these findings seem to indicate that in both groups , neurogenic inflammation is present and responsible for acyclical painful symptoms.Supplementary file1 (DOCX 13 KB)Below is the link to the electronic supplementary material.


What is the effectiveness of acupuncture and massage for cancer pain in patients with advanced cancer?In this randomized clinical trial that included 298 patients with advanced cancer, both acupuncture and massage were associated with long-term pain reduction. There was no significant difference between treatments.The findings of this study suggest that both acupuncture and massage may offer pain relief as integrative modalities in patients with advanced cancer. Pain is challenging for patients with advanced cancer. While recent guidelines recommend acupuncture and massage for cancer pain, their comparative effectiveness is unknown.To compare the effects of acupuncture and massage on musculoskeletal pain among patients with advanced cancer.A multicenter pragmatic randomized clinical trial was conducted at US cancer care centers consisting of a northeastern comprehensive cancer center and a southeastern cancer institute from September 19, 2019, through February 23, 2022. The principal investigator and study statisticians were blinded to treatment assignments. The duration of follow-up was 26 weeks. Intention-to-treat analyses were performed (linear mixed models). Participants included patients with advanced cancer with moderate to severe pain and clinician-estimated life expectancy of 6 months or more. Patient recruitment strategy was multipronged . Eligible patients had English or Spanish as their first language, were older than 18 years, and had a Karnofsky score greater than or equal to 60 .Weekly acupuncture or massage for 10 weeks with monthly booster sessions up to 26 weeks.The primary end point was the change in worst pain intensity score from baseline to 26 weeks. The secondary outcomes included fatigue, insomnia, and quality of life. The Brief Pain Inventory  was used to measure the primary outcome. The secondary outcomes included fatigue, insomnia, and quality of life.P = .07). Both treatments also improved fatigue, insomnia, and quality of life without significant between-group differences. Adverse events were mild and included bruising (6.5% of patients receiving acupuncture) and transient soreness (15.1% patients receiving massage).A total of 298 participants were enrolled . The mean (SD) baseline worst pain score was 6.9 (1.5). During 26 weeks, acupuncture reduced the worst pain score, with a mean change of −2.53  points, and massage reduced the Brief Pain Inventory worst pain score, with a mean change of −3.01  points; the between-group difference was not significant (−0.48; 95% CI, −0.98 to 0.03; In this randomized clinical trial among patients with advanced cancer, both acupuncture and massage were associated with pain reduction and improved fatigue, insomnia, and quality of life over 26 weeks; however, there was no significant different between the treatments. More research is needed to evaluate how best to integrate these approaches into pain treatment to optimize symptom management for the growing population of people living with advanced cancer.NCT04095234ClinicalTrials.gov Identifier:  This randomized clinical trial compares the effectiveness of acupuncture and massage as treatment for musculoskeletal pain in patients with advanced cancer. The benefit of massage remains uncertain as related to other interventions such as acupuncture.17In 2022, the American Society of Clinical Oncology and the Society for Integrative Oncology published a joint guideline recommending acupuncture and massage be considered for cancer pain management.18 Therefore, managing pain and comorbid symptoms is critical for quality of life in this growing population. Although acupuncture and massage have recently been recommended for treatment of cancer pain, to our knowledge, no studies have compared their effectiveness in advanced cancer populations. Furthermore, most randomized trials on pain interventions in patients with advanced cancer had only a short intervention or follow-up.20 To inform patients and health care professionals with evidence on how to make decisions on incorporating nonpharmacologic interventions for pain and symptom management, we conducted a randomized clinical trial to evaluate the long-term comparative effectiveness of acupuncture vs massage for pain and comorbid fatigue and insomnia in patients living with advanced cancer.With improvements in treatment, people are living longer with advanced cancer.21 All participants gave written informed consent; financial compensation was provided. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.The Integrative Medicine for Pain in Patients with Advanced Cancer Trial (IMPACT) is a pragmatic, 2-arm, parallel-group randomized clinical trial. The study  was apprTo ensure participant diversity, our recruitment strategy included patient database queries, letter mailings, clinician referrals, and community outreach and engagement. Recruitment sites included Memorial Sloan Kettering Cancer Center, a National Cancer Institute–Designated Comprehensive Cancer Center, with a main campus in Manhattan and regional sites in New York , New Jersey , and Florida .22 and had an advanced cancer diagnosis. Advanced cancer was defined as follows: stage III or IV lung cancer, any stage pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or periampullary cancer or other stage IV gastrointestinal cancer, stage III or IV ovarian or fallopian tube cancer or other stage IV gynecologic cancer, stage IV breast cancer, stage IV genitourinary cancer, stage III or IV sarcoma, stage IV melanoma, stage III or IV head/neck cancer, stage IV endocrine cancer, or hematologic malignant neoplasms . Patients were eligible only if they were deemed by a clinician to have an expected prognosis of 6 or more months.Patients were eligible if they were fluent in English or Spanish, they were older than 18 years, had a Karnofsky score greater than or equal to 60 ,3/μL .To be eligible, patients must have also reported musculoskeletal pain, defined as regional  or generalized , as the primary source of pain. The pain must have been present for at least 1 month and for at least 15 of the preceding 30 days. Patients must also have rated their worst pain intensity as 4 or greater on a numerical rating scale of 0 to 10. Patients were excluded if they had a platelet count less than 150 × 10Potential participants were screened by a research coordinator, and a study clinician confirmed their eligibility. After providing informed consent, participants completed baseline assessments and underwent randomization. Race and ethnicity data (from patients’ self-reports) were included to identify demographic characteristics associated with pain reduction from either intervention. Patients were randomized to acupuncture or massage in a 1:1 ratio on a secure computer system that ensured full allocation concealment and used permuted blocks stratified by baseline opioid use (yes vs no) and by accrual sites. The principal investigator (J.J.M.) and study statisticians (R.E.B. and K.S.P.) were blinded to treatment assignments. Participants completed patient-reported outcomes using Research Electronic Data Capture at weeks 0, 4, 10, 14, 18, 22, and 26.23 containing 4 pain severity items and 7 pain interference items rated on a scale from 0 to 10, with higher numbers indicating worse pain intensity or interference. The individual clinical response benchmark for BPI worst pain is a 30% improvement from baseline.24 To assess comorbid symptoms and health-related quality of life, we used the Brief Fatigue Inventory,25 the Insomnia Severity Index,26 and the Patient-Reported Outcomes Measurement Information System Scale, version 1.2 .27 We tracked use of analgesic medications  using weekly pain medication diaries. To monitor treatment safety, study therapists and research coordinators collected data on adverse events using the Common Terminology Criteria for Adverse Events, version 5.28The primary outcome was worst pain severity in the past week with response choices ranging from 0 (no pain) to 10 (pain as bad as you can imagine) measured by the short-form Brief Pain Inventory (BPI). The BPI is a reliable, valid, and responsive measure of pain (Cronbach α = 0.77-0.91)21Licensed and oncology-experienced acupuncturists and massage therapists delivered the treatments. All therapists received a manual with the treatment protocols for acupuncture and massage and were trained by the principal investigator (J.J.M.), lead acupuncturist, and/or lead massage therapist. The lead therapists audited at least 2 records for each therapist per week to ensure treatment fidelity. If treatments needed to be modified for medical reasons, therapists were instructed to document the details of the modifications with an accompanying rationale. The interventions have been described in detail previously.14 The acupuncturist manipulated needles to achieve de qi, a local sensation of soreness or distension that accompanies effective needling.29 The needles at the 4 local points for pain were electrically stimulated at 2 Hz using a transcutaneous electrical nerve stimulation unit. For participants with electronically charged medical devices, no electrical stimulation was used. Total treatment time was 30 minutes per session with needles left in place for 20 minutes.Acupuncturists placed 10 to 20 needles at a minimum of 4 local points around the body area with the most pain, as well as supplementary points at other locations, depending on the presence of comorbid symptoms. The acupuncture needles were inserted to appropriate depths based on the body type and point location.31Massage therapists started with a 5-minute protocol that included guided diaphragmatic breathing exercise, rib mobilizations, and occipital release designed to increase parasympathetic tone. Depending on the primary area of pain, the therapist focused 20 minutes of massage on that specific body area followed by effleurage toward the heart. Massage techniques were applied with light to moderate pressure and included compression, muscle stripping, active/passive range of motion, postisometric stretching, effleurage, myofascial release, positional release, and trigger point release for a total treatment time of 30 minutes.32 reflecting the prerandomization timing of the baseline assessment. The dependent variable vector included the baseline (week 0) BPI worst pain and all postrandomization assessments at weeks 4, 10, 14, 18, 22, and 26. The independent variables were the randomization stratification variables , treatment arm, week , and the arm-by-week interaction. A patient-level random intercept was included in the model to account for the repeated outcome measurements within patients. Linear mixed models provide valid inference under the reasonable assumption that missing follow-up data were missing at random.33 We therefore did not impute missing values. Results are reported as least square means, mean differences, and 95% CIs, with inferences regarding differences between arms based on model coefficients from the arm-by-week interaction. We prespecified comparisons between arms at 2 time points of interest: weeks 10 and 26. Differences in week 26 BPI worst pain was the primary end point of the study, allowing for evaluation of long-term treatment effects. Week 10 BPI worst pain was a secondary end point to evaluate the treatment effect at the end of treatment. We used similar models to analyze our continuous secondary outcomes. To analyze pain medication use (dichotomous), we used a generalized linear mixed model with logistic link function and with the arms constrained to have a common baseline probability of analgesic medication use. The analgesic medication use model was otherwise specified similarly to the models for the continuous outcome measures. We did not adjust the CIs for multiple testing of secondary outcomes. Because of the potential for inflated type I error due to multiple comparisons, results from analyses of secondary outcomes were interpreted as exploratory. We also conducted additional sensitivity analyses to evaluate whether pain medication use or COVID-19 treatment interruption had any influence on our primary outcome , the BPI worst pain score had an SD of 1.7. A 1-point difference is considered a minimal clinically meaningful difference in pain research.34 Given that a difference of 1 on the BPI worst pain scale, based on SD of 1.7, equals a Cohen d value of 0.59, the trial was sufficiently powered to detect a clinically meaningful difference between acupuncture and massage at 26 weeks.We calculated that with a sample size of 300, assuming 20% loss to follow-up by 26 weeks, Pearson correlation between baseline and 26-week BPI worst pain of 0.5 and 2-sided α of .05 would provide the trial with 80% power to detect a Cohen From September 19, 2019, through February 23, 2022, we screened 828 patients, and 528 were excluded due to ineligibility or unwillingness to participate. Of the 300 enrolled patients, 151 were randomly assigned to acupuncture and 149 to massage. Two patients did not provide baseline data and did not receive treatment; therefore, these 2 patients were excluded from the analyses. Among 150 individuals in the acupuncture group, 139 (92.7%) received at least 1 treatment and 92 (61.3%) completed 10 or more treatments. Among 148 individuals in the massage group, 139 (93.9%) received at least 1 treatment, and 99 (66.9%) completed 10 or more treatments. Among all participants, 56 (18.8%) withdrew from data collection at the week 26 primary end point .The demographic and clinical characteristics of the patients in the 2 groups were similar at baseline. The mean (SD) age of the patients was 58.7 (14.1) years, 200 (67.1%) were women, and 98 (32.9%) were men. Self-reported race and ethnicity, as categorized herein, were included to ensure diversity among research participants: 19 individuals (6.4%) were Asian, 33 (11.1%) were Black, 46 (15.4%) were Hispanic, 220 (74.1%) were White, and 25 (8.4%) were multiracial.A total of 78.5% of the patients had solid tumors. The most common cancer types were hematologic (21.5%), breast (19.8%), gynecologic (14.4%), and gastrointestinal (11.7%). Mean (SD) time since diagnosis was 5.6 (7.5) years. The mean (SD) score for worst pain severity was 6.9 (1.5), the mean (SD) pain duration was 3.8 (7.3) years, and 98 individuals (32.9%) were receiving opioids at baseline .d = 0.31; P = .07)  points, and massage reduced the BPI worst pain score, with a mean change of −3.01  points. The between-group difference in BPI worst pain reduction at week 26 was not significant  . More thBoth acupuncture and massage improved pain-related functional interference, fatigue, insomnia, and physical quality of life at week 26 relative to baseline . The proAdverse events were mostly mild. Among patients receiving acupuncture, bruising (6.5%), localized pain (5.8%), and bleeding (1.4%) were the most commonly reported adverse events. Among patients receiving massage, transient soreness (15.1%) and headache (1.4%) were the most commonly reported adverse events. There was no documented transmission of COVID-19 during the receipt of the study interventions.18In this randomized clinical trial comparing acupuncture and massage, both therapies were associated with pain reduction and improved fatigue, insomnia, and quality of life over 26 weeks; however, there were no significant differences for pain or secondary outcomes. More than half of the participants had a clinically meaningful response to treatment. Both therapies were delivered safely during the COVID-19 pandemic with only mild adverse events. The findings contribute to current guidelines for cancer pain management by demonstrating the long-term comparative effectiveness of 2 nonpharmacologic therapies in the growing population of patients living with advanced cancer.36 and cancer survivors with chronic pain.14 Consistent with prior research of pain in patients with cancer,37 acupuncture also reduced fatigue and insomnia, highlighting its capacity to jointly address multiple, co-occurring symptoms in a cancer population with a high symptom burden.The durable effects of acupuncture observed in this study are consistent with findings from other large randomized clinical trials of acupuncture for pain in the general population38 in patients with cancer receiving hospice care, but the improvements were not durable.16 Our study found massage was associated with reduced pain in both the short and long term; however, our intervention included booster treatments, monthly sessions for 4 months after the weekly sessions for 10 weeks, to consolidate the initial treatment effect. It is also possible that population differences may contribute to the observed differences, as our study enrolled patients living with advanced cancer rather than patients nearing the end of life. There may even be a small benefit of massage over acupuncture, albeit nonsignificant. The lack of difference between massage and acupuncture at week 26 confirmed that a course of massage therapy with booster sessions was likely to result in sustained pain reduction as previously reported in acupuncture studies.39Past oncology massage research has demonstrated short-term benefits for pain, mood, and quality of life41 In this trial, acupuncture and massage not only reduced pain but also improved comorbid fatigue and insomnia symptoms, underscoring the multifaceted benefits that integrative modalities can offer for this population. In this trial, interventions were provided in addition to pharmacotherapy for some patients, reflecting the clinical setting; therefore, our data should not be interpreted as drugs should be replaced by acupuncture or massage, but that these nonpharmacologic interventions can improve pain and symptom control while potentially reducing medication use.In patients with advanced cancer, pharmacotherapy is often the mainstay of pain management. However, polypharmacy is a growing concern in this population due to adverse effects and drug-drug interactions.43 Currently, Medicare only covers acupuncture for chronic low back pain and does not cover massage for pain.44 Given that patients with advanced cancer often have pain in multiple locations due to their disease and oncologic treatment, expanding Medicare coverage to include other pain locations, as well as massage, is needed to promote equitable and effective pain management for patients with cancer. More educational effort should also be directed at training acupuncturists or massage therapists on safe and effective practice for patients with advanced cancer. Furthermore, more research is needed to understand how best to integrate these nonpharmacologic treatments into the current pain management strategy to create patient-centered, efficient, and effective care.Both acupuncture and massage are popular integrative medicine approaches that are increasingly available in both academic and community cancer centers.35 the absence of a control arm in this study limits the capacity to interpret the extent to which the reduction in pain from baseline is attributed to the intervention and how much is due to a placebo effect. Second, patients and clinicians could not be blinded due to the nature of the interventions; however, the principal investigator and statisticians were blinded. Third, massage therapists had more patient-clinician contact time in the process of therapy delivery, but the treatment duration of 30 minutes was identical in both treatment groups. Fourth, it is possible that some of the improvement in pain may have been due to analgesic medication titration and/or tumor response to cancer therapy. However, controlling for medication use in sensitivity analyses did not impact our results or conclusions. In addition, while we longitudinally collected data  on tumor status , we did not perform independent review of adherence to cancer therapies or apply radiographic response evaluation criteria in solid tumors. Fifth, COVID-19 interrupted treatment for some patients; however, our results reflect the community setting effects of these treatments in the context of a pandemic. In additional sensitivity analyses, controlling for COVID-19–related treatment interruption did not change our results. Sixth, our therapists underwent rigorous training on safety and intervention delivery and had consistent fidelity monitoring; therefore, the results may not be generalizable in community settings, where there is wider variability in clinical care delivery.This trial has limitations. First, the study was designed as a pragmatic comparative effectiveness trial of 2 active interventions, so sham or usual care control groups were not used. Although both therapies have been shown to be superior to sham and usual care in prior research,In this randomized clinical trial, both acupuncture and massage were associated with reduction in pain and improved fatigue, insomnia, and quality of life among patients living with advanced cancer during 26 weeks. However, there was no significant difference between treatments.


BackgroundThird molar surgeries are commonly performed in oral and maxillofacial surgery practice. Pain associated with this procedure is usually a frequent reason for patient apprehension and discomfort. Oral analgesics, though effective, do not provide sufficient pain relief in the immediate postoperative period. AimTo assess the postoperative effect on pain levels of single-dose administration of ketoprofen and diclofenac sodium as an injection in patients undergoing third molar removal surgeries. MethodsThis study was conducted among 30 patients divided into two groups (n=15). Patients in Group K received injection ketoprofen 100 mg and Group D included patients receiving injection diclofenac sodium 75 mg, both intramuscularly postoperatively. The intensity of pain was assessed at 30 minutes, two, six, and eight hours post-surgical removal of the impacted tooth using the visual analogue scale (VAS). The statistical data was analyzed using SPSS for Windows version 23.0 . The comparative statistical test adopted to compare pain scores between the two groups was the Independent samples t-test. A p-value of <0.05 was considered to be statistically significant.ResultsOur study results revealed that Group K patient's VAS scores after two hours, six hours, and eight hours were 3.9 ± 2.7, 4.5 ± 3.23, 2.93 ± 2.27 respectively. In Group D patient's VAS scores after two hours, six hours, and eight hours were 4.83 ± 2.82, 5.03 ± 2.9, 3.73 ± 2.91 respectively. Patients who were administered ketoprofen had lower pain levels when compared to patients who were given diclofenac but the difference was not statistically significant at any time point (p=0.172 after eight hours). Our results depicted that the pain levels uniformly reached their maximal levels six hours after the procedure and thereafter steadily declined in both groups. ConclusionIt can be concluded from the study that both the drugs ketoprofen and diclofenac sodium analyzed in this study can be used interchangeably for the reduction of pain following lower third molar surgery. Among the several procedures performed by oral and maxillofacial surgeons, the removal of mandibular third molars is the most common and routinely performed procedure. However, pain management postoperatively is of utmost importance and still an area of concern. The pain and postoperative effects worsen with an increase in the difficulty of the impactions . EvidencPain after surgical removal of impacted wisdom teeth peaks three to six hours after surgery and then subsides after 12 hours ,7. HenceAmong the NSAIDs, diclofenac is a well-researched and commonly administered drug due to its anti-inflammatory, analgesic, and antipyretic properties . It has Diclofenac and ketoprofen are efficient in providing pain relief after surgical procedures, according to placebo-controlled trials . A singlStudy settingThe participants for the study were recruited from the outpatients of the Department of Oral and Maxillofacial Surgery, Saveetha Dental College and Hospital, Chennai, Tamil Nadu, India in patients presenting with a requirement for surgical removal of the impacted mandibular molar tooth. The Institutional Human Ethics committee had given approval for conducting the study (IHEC/SDC/OMFS-2104/22/186) and written consent was obtained from the participants. InterventionA total of 30 patients were included in the study. The sample size was determined using G power calculation on the basis of the study conducted by Velásquez et al. in 2014 , with a Assessment All the operated patients were admitted in the day care unit and patients were discharged after assessment of postoperative pain. The pain was assessed using a Visual Analogue Scale . Pain intensity at various time intervals was compared among the two groups. In both groups, postoperatively patients were prescribed antibiotics and analgesics for five days and 0.12% chlorhexidine gluconate mouthwash for a week. Inclusion criteriaPatients aged 18 years or older, presenting with Class II and position A or B, horizontal angulation (Winter's classification) impacted mandibular third molar were included. Patients who were willing for regular follow-ups were included.Exclusion criteriaPatients presenting with systemic diseases and any infections related to the tooth of interest were also excluded.Statistical analysisThe statistical data was analyzed using SPSS for Windows version 23.0 . All data were summarized as mean ± SD for continuous variables, numbers, and percentages for categorical variables. The comparative statistical test adopted to compare pain scores between the two groups was the Independent samples t-test. A p-value of <0.05 was considered to be statistically significant.The participants of the study were segregated into two groups, with 15 in each. All the patients were similar in their socio-democratic characteristics; thus, steps have been taken to minimize the confounding factors . The patients in the ketoprofen group showed a mild increase in the pain levels 30 minutes after the administration of the drug while those in the diclofenac sodium group showed comparatively lesser pain. However, these values were statistically not significant . Patients in both groups showed peak pain levels at the end of eight hours post-surgery after which the pain began to subside in both groups. Except at the start of the study, until the end of eight hours, the VAS scores were lesser in Group K when compared to Group D. Yet again, these values between the groups were statistically not significant  (Table Diclofenac sodium is a nonselective cyclooxygenase inhibitor. On the other hand, ketoprofen is a relatively newer medication that has been clinically tested and found to be safe as it has no impact on platelet functions. While NSAIDs have been shown to be beneficial, paracetamol alone is ineffective for treating acute postoperative pain. Previous studies have suggested that both ketoprofen and diclofenac have better effects on early postoperative pain when compared to paracetamol . The admA study conducted by Niemi et al. highlighted that diclofenac 1 mg/kg given 30 minutes prior and four hours after the surgery gives better pain control when compared to ketoprofen 1.35 mg/kg . OxycodoSeymour et al.  documentHowever, Olmedo et al. demonstrated that after third molar surgery, ketoprofen 50 mg and placebo produced superior analgesic efficacy than ketorolac 10 mg and 20 mg . AccordiKetoprofen additionally blocks the arachidonic acid cascade's lipoxygenase pathway, which inhibits the production of leukotrienes . It prevLimitations of the studyThe small sample size and absence of a placebo group were the limitations of this study. Placebo analgesia has been proven to play an important role in the pain alleviation experienced by patients. However, this fact does not invalidate the factors that predicted analgesia of the drugs used in our study or the study results. The future scope of the study would be to evaluate results on the larger sample size and assess the effectiveness of these drugs as a pre-emptive analgesic. In recent times, day-care surgery is currently being promoted for medical, social, and financial reasons. Therefore, the importance of NSAIDs in postoperative pain management is of utmost importance. It can be concluded from the study that the postoperative pain reduction was comparable between the two groups - ketoprofen and diclofenac sodium. However, ketoprofen group patients have lesser pain perception compared to the diclofenac sodium group patients. In future, multi-centric studies with larger sample size are required to validate this finding as well as the timings of administration, either preoperatively or postoperatively.


Pain severity was assessed using the visual analog scale (VAS), whereas disability was assessed using the Oswestry disability index (ODI). The difference in preoperative and postoperative ODI scores ≥ 15 points was used as a criterion for treatment effectiveness, and the difference in VAS scores ≥ 1 point was used as a criterion for pain reduction. In patients under general anesthesia, the procedure only included implantation of the DIAM system. Patients in the control group underwent conservative treatment, which included rehabilitation, a bed regimen, analgesic drug treatment and periarticular spinal injections of anti-inflammatory drugs. It was found that all patients (n = 43) continued to experience LBP after DIAM implantation (mean VAS score of 4.2). Of the 36 patients who experienced LBP with sciatica before the procedure, 80.5% (n = 29) experienced a reduction in pain. As for the level of fitness, the average ODI score was 19.3 ± 10.3 points. As for the difference in ODI scores in the pre-treatment results vs. after treatment, the average score was 9.1 ± 10.6. None of the patients required reoperation at 12 months after surgery. There were no statistically significant differences between the two groups in either early (p = 0.45) or long-term outcomes (p = 0.37). In conclusion, neurosurgical treatment with the DIAM interspinous stabilizer was as effective as conservative treatment and rehabilitation during the one-year follow-up period.Low back pain (LBP) is a leading cause of disability and work absenteeism. The cause of LBP may be degeneration of the intervertebral disc. LBP is characterized by considerable variability and tends to develop into chronic pain. Treatment of LBP includes conservative and rehabilitative treatments, surgery, and so-called minimally invasive treatment. One of the most commonly performed procedures is interspinous stabilization using a dynamic interspinous DIAM  stabilizer. There is still no clear, strong evidence for the effectiveness and superiority of surgical treatment over conservative treatment. This study aimed to compare the early and long-term outcomes of patients with LBP using the DIAM interspinous stabilizer in relation to patients treated conservatively. A group of 86 patients was prospectively randomized into two comparison groups: A ( The problem of degenerative lumbar spine disease (DLSD) and intervertebral disc degeneration disease (IDDD) has been considered from the point of view of several disciplines, from orthopedics and surgery through to histology and molecular biology . ArguablPopulation-based studies have shown that the annual incidence of a first LBP episode ranges from 6.3% to 15.4%, whereas the cumulative incidence of a first or any episode ranges from 1.5% to 36% . One-yeaUndoubtedly, LBP is the leading cause of reduced life activity and absenteeism from work worldwide and represents a huge economic burden on individuals, families, society and industry. Until recently, it was considered a problem mainly for highly developed countries; however, numerous studies have shown that it is just as serious in developing countries . The ecoIn response to social and “market” demand, a variety of therapeutic methods have been developed, including pharmacological, rehabilitative and broadly defined treatment methods ,15,16,17Dynamic stabilizers, such as DIAMs, are able to absorb and dissipate axial loads and thus reduce the stresses acting on the intervertebral joints . AnotherIt seems very important to verify the effectiveness of surgical management with DIAM interspinous stabilization compared with less aggressive conservative and rehabilitative management. Currently, there is still no clear, strong evidence in the literature on the effectiveness and superiority of surgical treatment over conservative treatment, especially from a long-term perspective . A systen = 43), treated with the DIAM dynamic stabilization system for DLSD (mean age = 43.4 years ± SD = 10.8 years), and B (n = 43), treated conservatively for DLSD at a neurosurgical outpatient clinic at the same time (mean age = 41.4 years ± SD = 12.8 years).The study was conducted in the Department of Neurosurgery at the Walbrzych Specialized Hospital (Poland). Nearly 80 surgical procedures for the neurosurgical implantation of the DIAM stabilization system in patients with DLSD were performed. Patients who did not return completed questionnaires one year after surgery despite being eligible for the study and treatment intervention were excluded from the analysis. This made it impossible to obtain complete data and follow-up observations for the treatment results. The final and complete study material consisted of 86 patients who were randomized to two comparison groups: A (The inclusion criteria for patient participation in the study were: (1) moderate to severe low back pain as measured using the visual analogue scale (VAS) secondary to DLSD lesions at one L3-S1 level, (2) LBP defined as persistent back pain with or without root pain (sciatica), with a duration of the current pain episode of at least several months, (3) chronic LBP with sciatica, confirmed by magnetic resonance imaging (MRI) , (4) IDDContraindications to surgical treatment and at the same time criteria for exclusion from the study were: (1) reduction in disc height > 60% at the involved level, (2) inflammation of the arachnoid membrane, (3) primary diagnosis of the cause of spinal discomfort other than DLSD in the involved segment, (4) DLSD requiring the surgical treatment of more than one level, (5) history of conservative treatment within 6 weeks before the planned surgery, (6) sequestration of herniated nucleus pulposus, (7) history of any surgery of the involved or adjacent level, (8) history of any intradiscal ablation procedure, (9) congenital or iatrogenic absence of posterior column elements , (10) underdevelopment or agenesis of the spinous process, (11) lower limb movement deficit, (12) cauda equina syndrome, (13) clinically significant peripheral neuropathy, (14) chronic ischemia of the lower extremities manifested by intermittent claudication, (15) history of traumatic fracture in L1–L5 segments, either compressive or with tearing, (16) lumbar scoliosis with a Cobb angle greater than 15°, (17) established osteoporosis, osteopenia or osteomalacia, (18) obesity with a BMI of ≥40, (19) documented allergy to silicone, polyethylene, titanium or latex, (20) active bacterial infection, (21) active neoplastic disease or a history of neoplastic disease within the past 5 years including spinal neoplastic disease, (22) anesthetic contraindications to general anesthesia, and the lack of patients’ informed consent.Patients in the study group underwent surgical treatment with implantation of the DIAM stabilization system. During surgery, all patients were placed in the prone position. The DIAM stabilizer , which is a dynamic implant, is constructed of silicone covered with a polyester mesh and is held in place using polyester bands. Implantation of the stabilizer was performed under general anesthesia, with the patient in the supine position with the least possible pressure on the abdominal cavity. The patient was placed in a position that provided a slight flexion of the operated spine in order to increase the distance between the vertebral arches and increase the surgical approach field. The operating table allowed X-ray viewing using the C-arm. The paravertebral muscles were detached bilaterally from the spinous processes at the level of the intervertebral joints using a standard technique, with the continuity of the joint capsules of the intervertebral joints preserved. With the help of a dissector, the interspinous space from the supraspinous ligament to the yellow ligament was prepared. Only the elements of the intercondylar ligament and any osteophytes were removed, creating enough space for implant placement. This was performed with (Kerrison) bone forceps and punches. Proper debridement of the muscle and ligament attachments from the spinous processes allowed for proper positioning of the implant wings. At this stage, ligament fenestration was performed to decompress the dural sac. The distraction was gradually increased until the supraspinatus ligament and the joint capsules of the intervertebral joints were smoothed and the proper lordosis of the operated segment was achieved. The proper alignment of the joints and the spaces between the vertebral arches were controlled by fluoroscopy. If an abnormally large force was required to achieve distraction, or if resistance was felt at some point during distraction, the cause may have been the presence of pathological bone bridges between vertebral arches that should be removed. Once the mobility of the adjacent vertebrae was restored, distraction was proceeded by placing the distractor as close to the yellow ligament as possible. The goal of the surgery was to optimally decompress the operated spinal level, hence in some cases it was necessary to perform removal of part of the articular processes and widening of the intervertebral foramen. The DIAM stabilization system was then placed in place of the distractor to maintain adequate decompression, allowing the operated segment to remain mobile. Several gauges were taken with the measuring tools included in the DIAM kit, measuring 8 mm, 10 mm, 12 mm and 14 mm, to select the appropriate implant size. The largest fitting implant was chosen, avoiding excessive distraction that can cause kyphosis and, in extreme cases, lead to a fracture of the spinous process. The implant was placed in the applicator with its proper cephalocaudal orientation before it was implanted in the appropriate location. Two methods of implant placement were used. The first version used the temporary excessive space distraction, which greatly facilitates the introduction of the DIAM system. The DIAM system in the space was pushed with a special tool so that it was directly over the yellow ligament. Once the system was optimally placed, the distractor was removed. The second method of implanting the DIAM stabilization system used a temporary distraction–application clip. Once the system was inserted into the interspinous space, the clip was removed. The DIAM system was attached to adjacent spinous processes with tapes. As recommended by the manufacturer, no drain was used. Perioperative antibiotic therapy was administered according to standard preoperative and postoperative protocols.Patients in the control group received individualized conservative treatment to reduce pain and improve spinal function and quality of life without surgical intervention. Pain medication and spinal periarticular injections of anti-inflammatory drugs were administered. Depending on the severity of the pain, oral analgesics (NSAIDs) were recommended. Comprehensive rehabilitation activities were carried out, which were planned based on the SMART principle with a view to defining specific, measurable, achievable, relevant and time-bound goals for the therapy. Priority measures included reducing pain, reducing muscle stiffness and improving range of motion, enhancing muscle strength and endurance and improving soft tissue flexibility. Exercises aimed at improving postural stability and posture correction in standing and sitting positions were used. From the scope of manual methods, relaxing massage of the lumbar spine area and joint mobilization techniques of the lumbar spine (tractions and glides) were used. Of the physical therapy treatments, electrotherapy treatments using transcutaneous electrical nerve stimulation (TENS) were used. Patients were also made aware of their body’s limitations and capabilities in relation to the secondary prevention of LBP. Conservative treatment was applied for a period of 6 weeks and was conducted according to standards of the same rehabilitation team under the supervision of the same attending physician. Treatments were conducted 5 days a week and lasted 2 h a day. An educational program on proper postural habits and techniques for avoiding spinal overload and healthy lifestyles was also provided ,28.The following data, acquired prospectively, underwent evaluation: (1) selected demographic data, (2) presence of pain and other discomforts before, immediately after and one year after surgery according to the VAS scale, (3) degree of disability using the ODI questionnaire before, immediately after and one year after surgery, (4) duration of surgery measured from skin incision to suture, (5) occurrence of other discomforts and ailments after surgery. The patients independently completed the VAS scale assessment and ODI questionnaire: before the surgery and immediately after the surgery while in the hospital and one year after the surgery, receiving it by mail. The assessment was based on the returned completed questionnaires. The following contributions were made by the team: M.P.-B. played a key role in conservative treatment, A.D. was responsible for performing neurosurgery procedure, A.D., M.M. and B.C. handled data collection and M.M. and J.R. were responsible for reporting functional complaints.The VAS pain scale is one of the most popular tools for measuring the subjective intensity of pain or other somatic sensations. It consists of presenting a line, usually 10 cm long, on which the patient marks their subjective sensation. When measuring pain, the VAS scale usually has extreme descriptions: on one side 0, meaning no pain, and on the other side 10, meaning the highest possible pain. Measuring on the VAS scale is quick and easy and provides accurate and reliable results. In the case of pain, measurement on the VAS scale can be conducted by the patient alone or assisted by members of the medical staff, who ask the patient to mark the spot on the line that best corresponds to the intensity of their pain. The VAS scale is widely used in clinical, epidemiological and therapeutic studies to assess the effectiveness of treatment for pain or other somatic sensations, including those of spinal conditions. In the present study, we assessed pain intensity “right now” to capture the immediate, current perception of pain by the patients. For the statistical analysis and standardization of measurements, pain severity on the VAS scale was divided into 3 categories: I—0–4, II—5–6 and III—7–10. During the LBP evaluation, a location division was made in LBP with or without sciatica .The ODI questionnaire is a diagnostic tool that is used to assess the degree of disability associated with back pain. The ODI consists of 10 questions about daily activities such as getting out of bed, walking, sitting up, lifting objects, sleeping, doing housework and self-care. Each question has 6 possible answers that are scored from 0 to 5, where 0 means no difficulty in performing the activity and 5 means not being able to perform it. The points obtained in each question are added up and the final score ranges from 0 to 100, where 0 means no disability and 100 means total inability to perform daily activities. The higher the ODI score, the greater the patient’s disability . We also analyzed the occurrence and severity of other complaints reported by the patient, such as numbness in the limbs, stumbling, problems straightening the torso, problems emptying the bladder on neurogenic grounds, abnormal skin sensation of the perineal area and impotence.Criteria for evaluating the early success of surgical treatment: patients treated with surgery were observed in the early post-operative stage for improvement in terms of pain/disability as measured by the ODI, a difference in preoperative and post-operative scores of ≥15 points, no complications related to the DIAM stabilization system used or to the procedure and no need for reoperation during hospitalization.Criteria of effectiveness of conservative treatment: patients treated conservatively were observed from the time for the decision not to undergo surgery, after 2 months of conservative treatment and one year after the beginning of follow-up. The criteria for treatment efficacy were identical to those for surgical patients.Criteria for treatment efficiency: (1) reduction in disability as measured by the ODI, described as a difference in scores between the start of follow-up and follow-up control points of ≥15 points (a difference of <15 points was considered ineffective) and (2) elimination and/or reduction of back and/or lower extremity pain measured by the VAS described as difference in pain intensity > 0 , lack of efficacy was considered if there was an absence of pain elimination or if pain became more intense (difference in VAS scores ≤ 0). The selection of a 1-point reduction in VAS scores as the criterion for clinical significance in our study, as opposed to the commonly employed 3-point benchmark, was guided by the specific context and objectives of our research. This decision was made to enhance the precision and applicability of our assessments, particularly in the early postoperative phase. The adoption of a 1-point reduction provides advantages in capturing nuanced changes in pain levels during this critical period following surgery.Approval from the Independent Bioethics Committee (IBC) at the Medical University of Wrocław was obtained . The study was conducted in accordance with the principles of good clinical practice (GCP), ensuring high quality, reliability and data security. During the study, the provisions of the Declaration of Helsinki (DoH) with regard to respecting patients’ rights were respected, in accordance with ethical and regulatory requirements. The Consolidated Standards of Reporting Trials (CONSORT) 2010 updated guidelines for reporting parallel group randomized trials were followed . Before the commencement of the study, a sample size calculation was conducted using Statistica 10.0  to ensure the statistical validity and reliability of the research findings. Based on the analysis of prior research findings and clinical expertise, it was determined that the new intervention was anticipated to yield a medium effect size of 0.5 concerning pain reduction in comparison with the standard treatment. The significance level for this study was established at 0.05, denoting a 5% probability of committing a type I error . To ensure statistical robustness, a power of 0.80 was targeted, indicating an 80% likelihood of identifying a genuine effect should it be present, thus mitigating the risk of a type II error. A two-tailed test was selected to enable the detection of any significant difference, irrespective of whether it manifested as an increase or decrease in pain. Following these considerations, it was determined that a total sample size of 80 individuals was required, with 40 participants allocated to each of the two groups under investigation.The study included statistical analyses on the relationship between various variables and the effectiveness of the treatment and the reduction in back and lower extremity pain. Age, duration of hospitalization and surgery time were described using the arithmetic mean, standard deviation and minimum and maximum measurements. The severity of pain on the VAS scale was divided into three categories: category I—0–4, category II—5–6 and category III—7–10. Statistical tests, including the chi-squared test with Yates’ correction, Fisher’s exact test, the Fisher–Freeman–Halton test, and Pearson’s chi-squared test, were used in the analyses. The statistical software used in the study was Statistica 10.0  and CytelStudio 10.0 . The study was conducted at a significance level of α = 0.05.The study included 86 patients, of whom 43 patients (mean age 43.4 ± 10.8 years) underwent neurosurgical treatment with the DIAM interspinous stabilization system and 43 patients (mean age 41.4 ± 12.8 years) were treated conservatively at a neurosurgical outpatient clinic at the same time . All of the 43 patients who experienced LBP before surgery continued to experience it after surgery. On average, the intensity of the pain experienced immediately after the procedure was 4.2. The average intensity of the pain experienced during the postoperative period was 4.1. The most severe back pain experienced in the postoperative period averaged 4.5. The average VAS back pain intensity scores before and immediately after the procedure are shown in Pain relief in the form of reduced overall LBP intensity occurred in 32 patients (74.4%). Thirty-one patients experienced a reduction in perioperative discomfort (shortly before and after surgery), six had no improvement in this area and six experienced an increase in pain. Twenty-five patients experienced a decrease in the average intensity of the pain felt, five patients had no change in the intensity of pain and nine patients experienced an increase in the average intensity of pain. In 33 patients there was a reduction in the discomfort described as the most severe one experienced by the patient, in 5 patients its intensity did not change and in the remaining 5 there was an increase in the severity of pain. On average, there was a decrease in the severity of pain experienced immediately before and after the procedure by 1.4 points on the VAS scale; the average pain experienced decreased by 2.1 points and the most severe pain experienced decreased by 1.5 points.Of the 36 patients who experienced lower extremity pain before surgery, all continued to experience lower extremity pain associated with sciatica in the postoperative period. On average, the intensity of the lower extremity pain experienced immediately after the procedure was 3.5 points. The average intensity of pain experienced in the postoperative period was 3.4 points. The most severe back pain experienced in the postoperative period averaged 4.1 points. The mean VAS lower extremity pain intensity scores before and immediately after the procedure are shown in It was found that 29 patients (80.5%) experienced a reduction in LBP with sciatica pain (difference in VAS scores before and after the procedure). In 29 patients there was a reduction in the discomfort experienced in the period immediately after the procedure, 5 patients showed no improvement in this regard and 3 patients experienced an increase in pain. Twenty-nine patients experienced a decrease in the patient’s average pain intensity, three experienced no change in their average pain intensity and four experienced an increase in their average pain intensity. Twenty-nine patients experienced a decrease in LBP with sciatica described as the most severe pain experienced by the patient, five patients had no change in pain intensity and the remaining two patients experienced an increase in pain intensity. Four patients did not improve in one or two types of pain, whereas the other five did not improve in terms of the severity of all three types of pain. In one patient , a root syndrome from sciatic nerve compression appeared only after surgery. On average, there was a decrease in the severity of LBP with sciatica felt immediately after the procedure by 2.6 points on the VAS scale, the average pain felt decreased by 2.3 points and the most severe pain felt decrease by 2.6 points compared with the same parameters studied before the procedure. The average score was 19.3 ± 10.3 points. The difference in ODI questionnaire scores  averaged 9.1 ± 10.6 points. Fourteen patients had a decrease in score of ≥15 points (32.6%), eighteen patients had a decrease in score from 1 to 14 points (41.9%), one patient had the same number of points before and immediately after the procedure (2.3%) and ten patients (23.2%) had an average increase of 6 points (from 3 to 10 points) .Compared with scores on the ODI questionnaire immediately after surgery, one year after surgery there was an average decrease in score of 0.4 ± 3.3 points . There was a decrease of 19 points in one patient, a decrease of 4 points in one patient, a decrease of 3 points also in one patient, a decrease of 2 points in five patients, a decrease of 1 point in six patients, scores did not change in 14 patients, six patients had an increase of 1 point, eight patients had an increase of two points and one patient had an increase of 3 points. A graphical representation of the difference in scores just after surgery and one year after surgery is shown in p = 0.45) and long-term (p = 0.37) disability reduction outcomes. The results are presented in Based on the adopted criterion of improvement according to the ODI (an improvement was considered to be at least a 15-point reduction in complaints), the results for the surgical patients and the patients treated conservatively for 2 months (early outcome) were compared. In the study group, improvement according to the accepted criteria was achieved in 14 patients (32.5%), whereas in the control group it was achieved in 15 patients (35%). The two groups were also compared one year after treatment (long-term outcome). In the study group, the number of patients with improvement did not change. In the control group, 16 patients (37%) showed improvement after one year. Statistical analysis using the chi-squared test showed no statistically significant differences between the two groups in both early  DIAM stabilizer treatment has a more effective analgesic effect immediately after surgery than conservative treatment after 2 months; (ii) DIAM stabilizer treatment has a more effective analgesic effect at 1 year after surgery than conservative treatment after 1 year; (iii) among the demographic and clinical variables analyzed, there are factors that give a better prognosis after surgery; and (iv) better results are obtained in the treatment of LBP without sciatica than LBP with sciatica in surgical patients. n = 43) who experienced LBP without sciatica before surgery continued to experience back pain after surgery (mean VAS score of 4.2). Of the 36 patients who experienced lower extremity pain before surgery, all continued to experience pain in the postoperative period (mean score of 3.5). In 29 patients (80.5%), there was a reduction in LBP with sciatica. The mean score on the ODI questionnaire at follow-up was 19.3 ± 10.3 points. The difference in ODI questionnaire scores in the pre-treatment vs. post-treatment results was 9.1 ± 10.6 points on average. At 12 months after surgery, none of the patients (n = 43) required reoperation. There were no statistically significant differences regarding disability between the two groups in both early (p = 0.45) and long-term (p = 0.37) outcomes using the ODI questionnaire, demonstrating the equal effectiveness of surgical and conservative treatments.The results show that patients . In the current literature one can find quite a number of works relating to the research topic under discussion. Sobottke et al.  analyzedThe goal of LBP treatment is to reduce pain and thus improve quality of life. In the present study, a difference in ODI questionnaire scores of 15 or more, representing a minimum clinically important difference (MCID), was used as a criterion for treatment efficacy. Its concept is proposed as a standard for evaluating the effectiveness of a given treatment method and in describing the patient’s satisfaction regarding a given method. In the literature, one can find different MCID values for the ODI—from 10.0 to 16.3 points . The MCIIn the present analysis, treatment was successful in only 32.6% (14 patients); the remaining patients did not meet the criteria for efficacy, which was considered at least a 15-point improvement in ODI score. Among these remaining 29 patients, 18 (41.9%) had a decrease in ODI scores not exceeding 14, one patient had no change in scores and 10 (23.2%) patients had an increase in scores . Compared with the scores on the ODI questionnaire collected just after surgery, one year after surgery there was an average decrease in score of 0.4 ± 3.3 points . Therefore, the treatment outcome remained the same during the one-year follow-up period. Heterogeneous treatment efficacy criteria do not allow direct comparison of the results obtained in this analysis with those of other researchers. p < 0.001). There was no correlation between intervertebral disc height on postoperative imaging studies and ODI score (p = 0.46). This study failed to link the clinical improvements with the changes in the radiology images and therefore confirm the mechanism of indirect intervertebral disc decompression.In the studies conducted to date on DIAM stabilization, improvements have been achieved in selected groups of patients. In a previously cited paper, Ha et al.  analyzedp = 0.005). Analysis of the results in the groups separated per-protocol (PP) also showed a statistically significant (p < 0.0001) reduction in disability at 2 months  and at 48 months after surgery  compared with before surgery. The mean scores were similar (p < 0.1934) in the months between 2 and 24 but significantly increased in the 24-month to 48-month follow-up period . The percentage of patients who achieved MCID (≥30% of RMDQ scores) between pre-treatment and 48-month follow-up was 78.9% in the ITT population and 80.8% in the PP population. Unlike in our study using the ODI questionnaire, their study used the one by Buric et al. [Buric et al.  are amonc et al. , i.e., tMariottini et al. , in theiSimilarly, a Czech study of 68 patients with LBP used the DIAM system alongside discectomy or foraminotomy and facetectomy . The VASKim et al.  conducteTM system. The evaluated factors included pain severity on the VAS, the ODI scale, the degree of disability on the RMDQ questionnaire, the pain-free walking distance and a subjective assessment of satisfaction with the procedure. Statistically significant (p < 0.001) improvements were obtained in all clinical parameters  in both groups. There were no significant differences between the two groups. At the two-year follow-up, the results were similar—there were no significant differences between the two groups in terms of the outcomes assessed. Here too, the conclusion is that a stabilizer as an addition to decompression surgery in spinal canal stenosis does not improve treatment outcomes. Similar results were obtained in the work of Richter et al.  on a groA systematic review and meta-analysis by Wu et al.  demonstrA large meta-analysis presented by Kaye et al.  covered p < 0.001), Dynesys  and Coflex  significantly reduced the incidence of radiographic adjacent segment degeneration (RASDeg) compared with spinal stabilization surgery alone. Spinal stabilization supplemented with DIAM significantly reduced the incidence of clinical adjacent segment disease (CASD) . Spinal stabilization supplemented with DIAM significantly reduced the incidence of radiographic and clinical adjacent segment disease. No significant differences were observed between the comparison groups with regard to reoperation for adjacent segment disease (ASD) and back pain relief scores.In turn, a 2022 meta-analysis by Chiou et al.  covered p = 0.083) toward better results than the group of patients with the Wallis system in place. In addition, there was no correlation between age and change in VAS score after surgery. Significantly higher VAS values were found in the preoperative evaluation in the women (p = 0.018); however, analysis of the VAS differences after surgery showed no significant gender dependence.The previously cited analysis by Sobottke et al.  covered In order to better distinguish the benefits obtained from the procedure, the present study separately analyzed LBP without and with sciatica in the course of the sciatic nerve compression. This separation makes it possible to determine the degree of impact of the procedure used on both discogenic pain and root pain. Pain relief in the form of a reduction in the intensity of overall back pain occurred in 32 patients (74.4%). On average, there was a 1.4-point decrease in the severity of pain experienced immediately before and after the procedure on the VAS scale. Pain relief in the form of reduced overall LBP with sciatica was achieved in 29 patients (80.5%). On average, there was a 2.6-point decrease in the severity of pain experienced immediately before and after the procedure on the VAS.In the study by Burica et al.  on a popn = 68), the average improvement in VAS score was 70.75% (from 7.19 points before surgery to 2.10 points after surgery). In individual subgroups, the differences in VAS before and after surgery were as follows: patients with intervertebral disc herniation experienced average drops of 5.42 points, patients with recurrent disc herniation—drops of 5.00 points and patients with intervertebral foramen stenosis—drops of 5.18 points. In patients after discectomy the decrease averaged 5.17 points, whereas after foraminotomy and partial facetectomy the decrease was 4.78 points. It should not be forgotten that in the cited work, the DIAM was always used in addition to the decompression procedure. In our study, the average decrease in VAS scores was 2.1 points for back pain and 2.6 points for lower extremities. However, in all patients, the reported decrease in pain intensity was the result of stabilizer implantation without a classic decompression procedure. In a Czech study  developed proprioception disturbances after the procedure, in the form of difficulty in assuming an upright posture, and one patient developed stumbling. Two patients developed a problem with erecting their torso (5.4%), one patient reported a problem with micturition (2.4%), one patient reported a problem with abnormal skin sensation of the perineal area (2.4%) and one patient reported impotence after the procedure (7.7%). In addition, postoperative wound pain was reported by 30 patients (69.8%) after surgery, a long hospital stay was annoying for 12 patients (27.9%), a long incapacity for work was annoying for 4 patients (9.3%) and 14 patients (32.5%) found the postoperative scar annoying. Such a low number of complications is due to the fact that the DIAM system implantation procedure is simple for an experienced neurosurgeon. The procedure is short , does not involve much blood loss and does not require special perioperative care. The patient can be mobilized within a short time after the procedure—as early as on the first day. These are huge advantages for this method that speak in favor of its use. The patient usually tolerates the procedure well and does not require long hospitalization.In the present study, no patient underwent reoperation during the one-year follow-up period. Follow-up is completed 12 months after the surgery and there are no data on reoperation (surgery of the segment on which the DIAM was placed) after this period. Given the fairly low success rate of the procedure, the likelihood of reoperation in subsequent years is high. It has been demonstrated that 8% of patients who underwent decompression surgery with implantation of the DIAM system due to spinal canal stenosis or intervertebral disc herniation will undergo reoperation within 4 years after the procedure. In the cited analysis, the reasons for reoperation were recurrent canal stenosis or intervertebral disc herniation, postoperative spondylolisthesis and long-term wound infections . The risThe present study stands out from the others in the available literature for its analysis of treatment outcomes using the DIAM system because of its relatively stringent efficacy criteria, homogeneous study group and adequately long follow-up period. Both groups of patients were recruited under the same conditions, at the same time and on an equal basis. The only difference was the patient’s own decision on further treatment. In addition, all patients were operated on by the same surgeon and treated conservatively by the same rehabilitation team. This approach has yielded results that do not share the enthusiasm of some of the cited authors but remain consistent with large analyses focused on the desirability of using the interspinous stabilizer alone. Compared with microdiscectomy, discectomy or decompressive laminectomy, the method of interspinous stabilization is relatively recent. Because classic surgeries have been performed for many years and are well known to every neurosurgeon, comparing new methods with them may be not meaningful. Although the implantation of the stabilizer itself is technically quite simple, the correct qualification of the patient for surgery requires experience, of which, in the case of this relatively new method, there is incomparably less than with the classical methods. Thus, it seems reasonable, as applied in the study, to compare the results of surgical treatment with conservative treatment, rather than with the other surgeries used. This study has some potential methodological limitations to be discussed. Including only patients undergoing isolated DIAM implantation in the study inevitably entails a significant reduction in the number of subjects studied. This procedure is considered by most surgeons as an adjunct to surgical methods with long-established efficacy. There may have been confounding factors such as psychological issues in the selection of both groups, the impact of which on treatment outcomes cannot be accurately assessed. Finally, during the observation period, only the DIAM implant was used for open interspinous stabilization. The choice of only one type of implant, on the one hand, allowed an accurate assessment of its effectiveness but, on the other hand, it may have been a suboptimal decision in some cases. In an era of very rapid development of interspinous stabilization methods, a larger array of implants will perhaps allow for more precise customization and better treatment results.Although our study used a clinical  and radiological (MRI) classifications for discogenic low back pain (LBP), it is important to acknowledge the limitations of this approach. In future studies, the incorporation of widely recognized classifications, such as the Quebec task force (QTF) classification, may offer valuable insights. The QTF classification provides a standardized framework for categorizing LBP patients, which can enhance the comparability of research across different institutions and facilitate a more comprehensive understanding of the condition. Utilizing such established classifications in future investigations could contribute to a more in-depth analysis of patient profiles, outcomes and treatment strategies, ultimately advancing our understanding of discogenic LBP and optimizing patient care.Neurosurgical treatment with the DIAM interspinous stabilizer was as effective as conservative treatment and rehabilitation during the follow-up period. Patients who had predominantly LBP rather than LBP with sciatica benefited more from the procedure. There is still a need for well-designed studies comparing medical procedures, both surgical and conservative, in the treatment of spinal pain in adults.


Background: Open mesh repair of inguinal hernia is acceptable and can be performed under local anaesthesia (LA). Individuals with high BMI (Body Mass Index) have often been excluded from LA repairs for varying reasons including safety concerns. Open repair of unilateral inguinal hernia (UIH) amongst individuals with different BMI groups was studied. Its safety profile was investigated using LA volume and length of operation (LO) as endpoints. Operative pain and patient satisfaction were also evaluated.Patients and methods: A total of 438 adult patients were studied having excluded underweight patients, those requiring any additional intra-operative analgesia, multiple procedures, or records with incomplete data. Operative pain, patient satisfaction, LO and LA volume were retrospectively studied from the existing data from clinical and operative notes.2 with BMI above normal at 62.8%. LO was 13-100 minutes (average 37 mins {SD = 12}) utilising an average LA volume of 45 ml (SD = 11) per patient. Across BMI groups, no significant difference in LO (P = 0.168) or patient satisfaction (P = 0.388) was seen. Although LA volume (P = 0.011) and pain score (P<0.001) demonstrated statistically significant differences, these did not appear to be clinically relevant. Over 90% in each BMI group experienced mild or no pain and with severe pain reported in only one patient in the entire population. Overall, LA volume required per patient was low and dosage was safe in all BMI groups with significant proportion (89%) of patients evaluated for satisfaction rating their experience ≥ 90 out of 100.Results: It was a predominantly male population  with an age range of 17-94 years peaking in the 60-69 years age group. BMI ranged 19-39 kg/mConclusion: LA repair is safe and well tolerated irrespective of BMI. BMI is not a viable reason for exclusion of obese/overweight individuals from LA repair. Body mass index (BMI) is a recognised means of comparing the weight and height of an individual serving as standard anthropometric tools . InguinaWorld Health Organisation (WHO) describes the “global epidemic of overweight and obesity as “globesity” with the UK experiencing an overall upward trend in the mean BMI in the last 25 years and the average resident being overweight -13. PatiGeneral anaesthesia (GA), regional anaesthesia (RA) and local anaesthesia (LA) with or without intravenous analgesia or sedation  are anaeThe findings of this article were presented as a dissertation by the first author in the attainment of a ChM in General Surgery from the University of Edinburgh, College of Medicine and Veterinary Medicine in 2019. The findings of this article were presented as a poster at the 41st Annual EHS congress 2019, Hamburg, September 11th-14th, 2019.We hypothesised that LA use in repair of unilateral inguinal hernias is safe and effective in overweight and obese patients. We studied the use of LA in open approach to treat inguinal hernias in normal, overweight and obese individuals evaluating operative pain score and patient satisfaction following LA inguinal hernia repair as well as safety of LA in different BMI groups .2) and those who required multiple procedures in the same sitting or any other form of analgesia intra-operatively. Furthermore, 185 patients audited in the first five years additionally had their satisfaction scores recorded within one hour of completing the procedure and this group had further evaluation of their patient satisfaction. Using anthropometric parameters (weight and height), Body Mass Index (BMI) was grouped based on the World Health Organisation (WHO) classification [2), overweight (BMI 25-29.9 Kg/m2) or Obese (BMI ≥30 Kg/m2).This was a retrospective study of patients who had open mesh repair of IH under LA supervised by a single consultant between 2010 and 2018. Permission to audit this data was sought and was obtained from the West Suffolk Hospital, Bury St Edmunds, UK and BMI Hospital, Bury St Edmunds, UK where all the procedures were performed. The clinical notes and operative records of patients who met the set criteria were reviewed. Of 471 consecutive patients identified . The procedures were performed using a standardised local anaesthesia mix constituted of 106 ml aliquots . The operating surgeon performed preoperative field infiltration and ilioinguinal blockade using the buffered local anaesthetic solution. Each patient was provided with a dedicated team member who talked to them throughout the procedure, they engaged the patients in a positive way, provided attention control and avoided sympathising using negatively-loaded words as described by Lang et al. .Data collection tools included patient records, theatre records, visual analogue pain scale, and visual analogue patient satisfaction scales aided by a data collection proforma. Information collected include patient demographics, volume of LA used, duration of procedure, duration of surgery, operative pain score  and patient satisfaction proforma with the pain score and patient satisfaction scores collected as previously described. The subjective visual rating scale (VAS) was on a 100 mm long line anchored by two verbal descriptors at each extreme (no pain and severe pain). The subset of the patients who also had their satisfaction assessed at the same time utilised a visual scale .Collected data was collated and analysed using IBM Statistical Package for Social Science (SPSS) for Windows, Version 24.0 . Thirty-three patients were not included based on the exclusion criteria., of the 438 patients included, 185 patients were evaluated on their overall satisfaction during the audit. Descriptive statistics include the age , gender and BMI characteristics of the population. The pain score, length of operation (minutes), volume of LA used as well as the patient satisfaction scores were evaluated. The VAS score was interpreted as follows no pain (0-4 mm), mild pain (5-44 mm), moderate pain 45-74 mm) and severe pain (75-100 mm) ,33. Age 2 (SD = 3.4) ranging 19 -39 kg/m2. Out of the total 50.2% of the participants were overweight, 12.6% were obese while the remaining 37.2% had a normal BMI. Majority of the young patients, one out of every two, had a normal BMI and only 4.4% of them being obese. Out of all elderly patients, 11.2% were obese and 46.4% were overweight. The distribution pattern amongst the middle-aged individuals differed with over half of them (57.4%) being overweight with this group additionally having the largest proportion of obese patients (16.6%).This population was predominantly male with only 34 (7.8%) of the patients being females. They were aged 17-94 years with an average age of 64 years (SD = 14) and a peak in the 60-69 years age group. The mean BMI overall, was 25.9 kg/mThe length of operation ranged between 13 and 100 minutes with an average of 37 minutes (SD = 12). Of the 106 ml aliquots of LA prepared for use for each patient, a minimum of 14 ml and a maximum of 90 ml were used to achieve anaesthesia with an average of 45 ml (SD = 11). Overall, the duration of the procedure did not significantly vary amongst the different BMI groups. This respectively averaged 36 mins, 38 mins, and 37 mins amongst normal, overweight and obese patients (P = 0.168). The overweight patients and obese patients averagely required 47 ml of LA for their procedure while individuals with normal BMI required less (43 ml). Although this was statistically significant (P = 0.011), the difference of 4 ml in the average volumes and the volumes being well within the safety limits of the LA renders this difference clinically irrelevant.Pain assessment with a Visual Analog Scale (VAS) was performed for all 438 participants. The mean VAS score was 18 (SD = 15), the lowest, 0 out of 100, was present in 9.8% of patients and the highest recorded pain score 80 was present in only one patient. 96.3% had VAS ≤50. Only 16 out of 438 patients had VAS above 50. On categorisation of the VAS, 15.5% had no pain, majority 77.2%) had mild pain, 7.1% had moderate pain and only 1 patient (0.2%) patient had severe pain. The average pain score was highest amongst the overweight individuals 21 (SD = 16) compared to obese individuals (18 SD = 16) and individuals with normal BMI (15 SD = 13). Although this difference in their pain score was statistically significant (P = <0.001), all the means were clinically within the mild pain category. Additionally, 89.5 % of these overweight individuals experienced either no pain or only mild pain. However, in comparison with other BMI categories, the overweight patients had the highest proportion of individuals in their group with moderate pain (10%) compared to 5.5% and 3.7% respectively amongst obese individuals and those with a normal BMI (Table % had milMean volume of LA (ml) required increased across pain categories 42 ml, 46 ml, 52 ml, and 58 ml progressing from no pain to severe pain (P<0.001). Furthermore, with ascending pain category, length of operation increased while patient satisfaction diminished Figure . Of the Open IH repairs are recognised as a safe and effective approach to repairing inguinal hernias. Male preponderance demonstrated (92.2%) is similar to most reports reflecting the significantly higher lifetime risk of this condition amongst males ,34. The The mean BMI in this study population is within the overweight category with about two-thirds being obese or overweight especially middle-aged individuals ,12,37. RIn most instances, inguinal hernia repairs last less than an hour avoiding patient discomfort on the operating table that can occur with a long operative procedure in awake patients. Here, the procedure averagely lasted 37 minutes and the longest lasted 100 minutes. The short duration allows most patients to remain comfortable and lie relatively still throughout the operation with adequate coverage by the duration of action of the LA. Sanjay and Woodward  using a Majority of the patients (92.7%) experienced either mild pain or no pain at all throughout their procedure and no patient experienced severe pain. There was no administration of any systemic analgesic and no conversion to general anaesthesia in all the patients. Lang et al.  studied Patients with BMI above normal should not be denied LA repairs because of potential safety issues that may arise with required dosage necessary for satisfactory intra-operative pain control. The administration of LA requires minimal resources and can easily be fitted into already available facilities available to an institution offering minor and intermediate surgical procedures as specialised equipment is not required. It is easily a surgeon-led procedure that avoids the need for an anaesthetist  while prLimitationsThis was a retrospective review which was dependent on existing data and therefore satisfaction scores were only evaluated amongst patients treated in the first five years of the study period at which time satisfaction scores were also recorded. This study is at risk of selection bias which may have occurred during the booking of the inguinal hernia patients for local anaesthesia approach. Also, pain and satisfaction assessment tools were subjective parameters. This study only evaluated intra-operative use of local anaesthesia without documenting early and late postoperative complications.Day case procedures under LA are an invaluable tool in the care of symptomatic hernias both in high and low risk patients. It is a strategic tool in the repertoire of a complete hernia service, significantly improving costs allowing provision of services without specialised anaesthetic care in most instances, also resulting in improved day-case rates of IH. Pain control was similar irrespective of a BMI and age, and the operating time and volume of LA used did not significantly vary with the patient’s BMI. BMI should not be the sole reason for not offering or administering LA for open inguinal hernia repair to a patient requiring a unilateral open inguinal hernia procedure. Team members should be made aware of their ability to significantly impact outcomes by their choice of words and body language. Despite the presence of other treatment approaches, including GA-based repairs and laparoscopic repairs in the institutions of this study, LA hernia service remains a robust service in use in emergency and elective settings.