Numerical Rating Score Research Articles

Esketamine opioid-free intravenous anesthesia versus opioid intravenous anesthesia in spontaneous ventilation video-assisted thoracic surgery: a randomized controlled trial.

Opioid-free anesthesia (OFA) provides adequate analgesia and can reduce postoperative opioid consumption, but its efficacy in spontaneous ventilation video-assisted thoracic surgery (SV-VATS) has not been demonstrated. We aimed to investigate the hypothesis that OFA could provide the same perioperative pain control as opioid anesthesia (OA), maintain safe and stable respiration and hemodynamics during surgery, and improve postoperative recovery. Sixty eligible patients (OFA group: n=30; OA group: n=30) treated between September 15, 2022, and December 15, 2022, at The First Hospital of Guangzhou Medical University were included. They were randomized to receive standard balanced OFA with esketamine or OA with remifentanil combined with sufentanil. The primary outcome was the pain numeric rating score (NRS) at postoperative 24 h, and the secondary outcomes were intraoperative respiratory and hemodynamic data, opioid consumption, vasoactive drug dosage, and recovery in the post-anesthesia care unit and ward. There was no significant difference in the postoperative pain scores and recovery quality between the two groups. The OFA group had a significantly lower dose of phenylephrine (P=0.001) and a lower incidence of hypotension (P=0.004) during surgery. The OFA group resumed spontaneous respiration faster (P<0.001) and had a higher quality of lung collapse (P=0.02). However, the total doses of propofol and dexmetomidine were higher (P=0.03 and P=0.02), and the time to consciousness was longer (P=0.039) in the OFA group. OFA provides the same level of postoperative pain control as OA, but it is more advantageous in maintaining circulatory and respiratory stability and improving the quality of pulmonary collapse in SV-VATS.

Chronic pain patients and time to sustained acceptable pain scores after major surgery - A retrospective registry analysis

Study objectiveWe tested the hypothesis that pre-existing chronic pain is associated with prolonged time to reach sustained acceptable pain scores after major surgery. DesignRetrospective study using the German Network for Safety in Regional Anaesthesia and Acute Pain Therapy registry. SettingOperating rooms and surgical wards. Patients107,412 patients recovering from major surgery who were cared for by an acute pain service. 3.3% of the treatments were in patients who reported chronic pain with functional or psychological impairment. Interventions and measurementWe compared time to sustained adequacy of postoperative pain control defined by numeric rating scores <4 at rest and with movement in patients with and without chronic pain using an adjusted cox proportional hazard regression model and Kaplan-Meier analysis. The observation period was censored at 10 days and propensity score matching was used as a sensitivity analysis. Main resultsPostoperative pain at rest took significantly longer to resolve in patients with chronic pain than in those without (adjusted hazard ratio HR 1.42, 95% CI 1.36–1.49, P < 0.001). Postoperative pain with movement took even longer to resolve in patients with chronic pain (adjusted HR 1.65, 95%CI 1.56–1.75, P < 0.001). ConclusionsPatients with chronic pain sustain more surgical pain than those without, and the pain takes longer to resolve. Clinicians providing postoperative pain management should consider the special needs of chronic pain patients.

Does virtual reality technology reduce pain and anxiety during outpatient hysteroscopy? A randomised controlled trial.

To evaluate the effectiveness of virtual reality technology in reducing pain and anxiety during outpatient hysteroscopy. A prospective randomised controlled trial. A London University Teaching Hospital. Women aged 18-70 years undergoing outpatient hysteroscopy procedures. An unblinded randomised controlled trial was performed between March and October 2022 comparing standard outpatient hysteroscopy care with standard care with the addition of a virtual reality headset playing a virtual reality immersive scenario as a distraction technique. Pain and anxiety numeric rating scores (NRS) from 0 to 11. Eighty-three participants were randomly allocated to the control (n = 42) and virtual reality groups (n = 41). The virtual reality group experienced significantly less anxiety during the procedure than the control group (mean NRS 3.29 versus 4.73, mean difference 1.50; 95% confidence interval [CI] 0.12-2.88; P = 0.03). There was no difference in reported average pain (mean NRS 3.73. versus 4.24, mean difference 0.51; 95% CI -1.76 to 0.64; p = 0.41) or maximum pain scores (mean NRS 5.32 versus 5.07, mean difference 0.25; 95% CI -1.05 to 1.55; P = 0.71). The use of virtual reality technology as an adjunct to standard care can reduce patient-reported anxiety but not pain during outpatient hysteroscopy procedures. Continued improvements in the technology and the development of increasingly immersive environments may continue to increase the potential to improve the patient experience in this setting.

Change in perioperative neutrophil-lymphocyte ratio as a potential predictive biomarker for chronic postsurgical pain and quality of life: an ambispective observational cohort study.

Accurate and accessible predictors of chronic postsurgical pain (CPSP) to identify high-risk postsurgical patients are prerequisite for preventive and interventional strategies. We investigated the incidence and risk factors of CPSP after abdominal surgery, with a focus on plasma immunological markers. This was a retrospective analysis of patients who underwent abdominal surgery under general anesthesia at a tertiary center between January 2021 and January 2022. The preoperative demographics, laboratory test data, and surgical factors of the participants were collected from the electronic medical record system. Postoperative pain intensity and living conditions at 1 year after discharge from the hospital were assessed via a phone survey. Univariate and multivariate analyses were used to explore independent risk factors associated with CPSP. A total of 968 patients were included, and 13.53% (n = 131 of 968) of patients reported CPSP 1 year after surgery. Patients with older age, open surgery, higher American Association of Anesthesiologists classification, patient-controlled intravenous analgesia application, longer surgery duration, higher postoperative absolute neutrophil count, and neutrophil-lymphocyte ratio (NLR), lower postoperative absolute lymphocyte count, and higher white blood cell count, were more likely to suffer from CPSP. A changed ratio of NLR (postoperative to preoperative) ≥ 5 significantly correlated with CPSP, moderate to severe pain, maximum numeric rating score since discharge from the hospital, and affected quality of life. The changed ratio of NLR could be used for the early identification of patients at risk for CPSP and affect the quality of life to alert the clinician to undertake further assessment.

Preoperative Intravenous Dexamethasone and Postoperative Analgesia Following Breast Surgery: A Prospective, Randomized Double-Blind Trial at a Tertiary Healthcare Facility in Ghana.

Breast surgery may be associated with significant postoperative pain and if not adequately treated, may lead to the development of chronic post-surgical pain. This necessitates the use of effective management, involving the use a multimodal analgesia regimen for the management of post breast surgery pain. The analgesic effect of perioperative use of dexamethasone has been explored but findings have been inconsistent. The aim of this study was to determine the postoperative analgesic enhancing effect of a single preoperative dose of dexamethasone on patients undergoing breast surgery at a tertiary hospital in Ghana. This was a prospective, double-blind, placebo-controlled study involving 94 consecutively recruited patients. Patients were randomized into two groups: dexamethasone (n = 47) and placebo (n = 47). Patients in the dexamethasone group had 8mg (2 mL of 4 mg/mL) dexamethasone and those in the placebo group had 2 mL of saline administered intravenously just before induction of anaesthesia. All patients received a standard general anaesthesia with endotracheal intubation. The numerical rating score (NRS), time to first analgesic request and the total opioid consumed in the first 24 h were recorded. Patients receiving dexamethasone had lower NRS scores at all measured time points but this was significant only at 8 h post-surgery (P = 0.037). The time to first rescue analgesia was significantly prolonged in the dexamethasone group (339.26 ± 312.90 min vs. 182.10 ± 166.72 min; P = 0.020). However, the mean total opioid (pethidine) consumed in the first 24 h postoperatively was not significantly different between the dexamethasone and control groups (113.75 ± 51.35 mg vs. 100.00 ± 60.93 mg; P = 0.358). A single preoperative dose of 8mg dexamethasone given intravenously, reduces postoperative pain compared to placebo, significantly reduces the time to first analgesia but not the total opioid consumed in the first 24 h post breast surgery.

439 Percutaneous Electrical Nerve Stimulator for Treatment of Chronic Spinal Pain

INTRODUCTION: The percutaneous electrical nerve stimulator (PENS) is a relatively new device for the treatment of chronic spinal pain. This programmable device is worn for a recommended 10 to 12 days on the external ear, stimulating the auricular vagus nerve. It is postulated to release endorphins and relieve pain. There is minimal literature on the use of PENS as an adjunct to pain management in patients with chronic spinal pain. METHODS: Patients who had the PENS placed for chronic refractory spinal pain were included in the study. All patients failed multiple forms of treatment such as physical therapy, epidural steroid injections, and medication. RESULTS: In 2021, 114 patients had the PENS placed. The mean patient follow-up was 34.9 weeks. 67 patients (58.7%) felt pain relief due to the PENS. In patients with neck pain, the mean Neck Disability Index scores decreased from 43.8% to 25.4%, and the mean Numerical Rating Scores (NRS) decreased from 7.9 to 3.9. In patients with low back pain, the mean Oswestry Disability Index scores decreased from 47.6% to 33.5%, and the mean NRS scores decreased from 7.9 to 5.1. The rate of improvement in patients with neck pain (71.9%) was significantly greater (p-value &lt;0.02) than in patients with back pain (56.4%). Interestingly, 33.3% of patients who responded to treatment remained improved at one year follow-up. CONCLUSIONS: Our study shows that a significant number of patients experienced reduced pain and disability as a result of treatment with the PENS. Patients with neck pain responded better than patients with low back pain. Many patients in this difficult patient population experienced durable relief, lasting over one year. Our study suggests that the PENS may be a useful adjunct in the management of patients with chronic spinal pain.

Electrochemotherapy in radiotherapy-resistant epidural spinal cord compression in metastatic cancer patients

ObjectiveTo report efficacy and safety of percutaneous electrochemotherapy (ECT) in patients with radiotherapy-resistant metastatic epidural spinal cord compression (MESCC). Material/ methodsThis retrospective study analyzed all consecutive patients treated with bleomycin-based ECT between February-2020 and September-2022 in a single tertiary referral cancer center. Changes in pain were evaluated with the Numerical Rating Score (NRS), in neurological deficit with the Neurological Deficit Scale, and changes in epidural spinal cord compression were evaluated with the epidural spinal cord compression scale (ESCCS) using an MRI. ResultsForty consecutive solid tumour patients with previously radiated MESCC and no effective systemic treatment options were eligible. With a median follow-up of 5.1 months [1–19.1], toxicities were temporary acute radicular pain (25%), prolonged radicular hypoesthesia (10%), and paraplegia (7.5%). At 1 month, pain was significantly improved over baseline (median NRS: 1.0 [0–8] versus 7.0 [1.0–10], P < .001) and neurological benefits were considered as marked (28%), moderate (28%), stable (38%), or worse (8%). Three-month follow-up (21 patients) confirmed improved over baseline (median NRS: 2.0 [0–8] versus 6.0 [1.0–10], P < .001) and neurological benefits were considered as marked (38%), moderate (19%), stable (33.5%), and worse (9.5%). One-month post-treatment MRI (35 patients) demonstrated complete response in 46% of patients by ESCCS, partial response in 31%, stable disease in 23%, and no patients with progressive disease. Three-month post-treatment MRI (21 patients) demonstrated complete response in 28.5%, partial response in 38%, stable disease in 24%, and progressive disease in 9.5%. ConclusionsThis study provides the first evidence that ECT can rescue radiotherapy-resistant MESCC.

Efficacy and Safety of Roflumilast Foam 0.3% in Patients With Seborrheic Dermatitis in a Phase 3 Trial

Introduction: Seborrheic dermatitis (SD) is a common, chronic, inflammatory dermatosis that affects patients of all ages with a global prevalence ≥5%. Treatments usually consist of topical therapies, including antifungals and low potency corticosteroids; however, current treatments have limitations such as side effects with long-term use and/or vehicles that can be difficult to use on both hair-bearing and non-hair-bearing areas. Roflumilast is a selective, nonsteroidal, highly potent phosphodiesterase-4 inhibitor once-daily foam under investigation for the treatment of SD. Efficacy, safety, and local tolerability of roflumilast foam 0.3% in patients with SD were demonstrated in a phase 2a and subsequent open-label trial (NCT04091646 and NCT04445987, respectively). Here, we present efficacy, safety, and local tolerability in a phase 3 trial of roflumilast foam 0.3% in patients with SD (NCT04973228). Methods: This phase 3 randomized, parallel group, double blind, vehicle-controlled trial was conducted in patients ≥9 years old with at least moderate SD affecting scalp and/or non-scalp areas. Patients were randomized 2:1 to apply once-daily roflumilast foam 0.3% (n=304) or vehicle (n=153) for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) Success (IGA of Clear or Almost Clear plus ≥2-grade improvement from baseline) at Week 8. Secondary efficacy endpoints included IGA score of Clear at Week 8, achievement of ≥4-point improvement from baseline in Worst Itch Numeric Rating Score (WI-NRS) among patients with baseline score ≥4 (WI-NRS Success), Overall Assessment of Erythema score of 0, and Overall Assessment of Scaling score of 0. Safety and local tolerability were also evaluated. Results: Overall, significantly more roflumilast-treated patients than vehicle-treated patients achieved the primary efficacy endpoint of IGA Success (79.5% vs. 58.0%; P&lt;0.0001) and IGA status of Clear (50.6% vs. 27.7%; P&lt;0.0001) at Week 8. Percentages of patients achieving IGA Success and IGA Clear at Weeks 2 and 4 were also greater with roflumilast. Significantly greater percentages of roflumilast- than vehicle-treated patients achieved secondary endpoints of WI-NRS success at Weeks 2, 4, and 8 (62.8% vs. 40.6%; P&lt;0.0001); Overall Assessment of Erythema score of 0 (57.8% vs. 32.0%; P&lt;0.0001) at Week 8; and Overall Assessment of Scaling score of 0 (58.1% vs. 36.5%; P&lt;0.0001) at Week 8. Local tolerability was favorable, with ≥98.9% of patients having no evidence of irritation at Weeks 4 and 8 on investigator-rated assessments and ≥92.3% of patients reporting a score of 0 (no sensation) or 1 (slight warm, tingling sensation; not really bothersome) after application on patient-rated tolerability. Overall incidence of treatment-emergent adverse events (TEAE), serious adverse events, and TEAEs leading to discontinuation were low, with similar rates between roflumilast and vehicle. Conclusion: Once-daily roflumilast foam provided improvement across multiple efficacy endpoints vs vehicle while demonstrating favorable safety and tolerability in patients ≥9 years old with SD affecting scalp and/or non-scalp body areas. Sponsored by Arcutis Biotherapeutics, Inc.

Efficacy and safety of baricitinib treatment for moderate to severe atopic dermatitis in real-world practice in Japan.

The authors evaluated the efficacy and safety of baricitinib, a Janus kinase 1/2 inhibitor, for atopic dermatitis (AD) in real-world practice. From August 2021 to September 2022, 36 patients aged ≥15 years with moderate to severe AD were treated with oral baricitinib 4mg/day plus topical corticosteroids. Baricitinib improved clinical indexes; the percent reduction at weeks 4 and 12 was a median of 69.19% and 69.98% for the Eczema Area and Severity Index (EASI), 84.52% and 76.33% for the Atopic Dermatitis Control Tool, and 76.39% and 64.58% for Peak Pruritus Numerical Rating Score, respectively. The achievement rate of EASI 75 was 38.89% and 33.33% at weeks 4 and 12, respectively. The percent reduction of EASI in the head and neck, upper limbs, lower limbs, and trunk was 56.9%, 68.3%, 80.7%, and 62.5% at week 12, respectively, with a significant difference between the head and neck versus the lower limbs. Baricitinib decreased thymus and activation-regulated chemokine, lactate dehydrogenase, and total eosinophil count at week 4. Baseline EASI of the head and neck negatively correlated with percent reduction of EASI at week 4, while baseline EASI of the lower limbs positively correlated with percent reduction of EASI at week 12. Treatment-emergent adverse events included elevation of creatine phosphokinase (11.1%), herpes labialis (5.6%), furuncle (8.3%), and exacerbation of AD (1%), without serious treatment-emergent adverse events. In this real-world study, baricitinib was well tolerated for patients with AD and achieved therapeutic effects comparable to those in clinical trials. High baseline EASI of the lower limbs might predict good treatment response at week 12, while high baseline EASI of the head and neck might predict poor treatment response at week 4 in baricitinib treatment for AD.

Analgesic efficacy of inter-semispinal fascial plane block in Patients undergoing Cervical Spine Surgery through Posterior Approach: a randomized controlled trial

BackgroundPosterior cervical spine surgery is commonly performed in elderly patients with significant comorbidities and is considered one of the most painful surgical procedures. Accordingly, perioperative pain management during posterior cervical spine surgery represents a unique challenge for anesthesiologists. Inter-semispinal plane block (ISPB) represents a promising analgesic technique for spine surgery through the blockade of the dorsal rami of the cervical spinal nerves. The present study aimed to investigate the analgesic effect of bilateral ISPB as an opioid-sparing nerve block technique for posterior cervical spine surgeries. MethodsThis prospective randomized controlled trial enrolled 52 patients planned for cervical spine surgery via the posterior approach. Patients were randomly assigned to one of two groups in a one-to-one ratio, with 26 patients allocated to the block group (ISPB) who received general anesthesia preceded by bilateral ISP using 20 mL 0.25% bupivacaine on each side and the remaining 26 patients allocated to the control group who received general anesthesia only. The primary outcome was total perioperative opioid consumption through two co-primary outcomes, i.e. total amount of fentanyl administered intraoperatively and total morphine consumption during the first 24 hours postoperatively. The secondary outcomes included intraoperative hemodynamic parameters, assessment of numerical rating scores (NRS) during the first 24 hours postoperatively, time to first rescue analgesia and opioid-related side effects. ResultsA significantly lower amount of intraoperative fentanyl was administered in the ISPB group (median, 175 μg; range, 110–220 μg] compared to the control group [median, 290 μg; range 110–350 μg). Patients in the ISPB group consumed significantly lower doses of morphine (median, 7 mg; range, 5–12 mg]) within the first 24 h postoperatively compared to the control group (median, 12 mg; range, 8–21 mg). In addition, NRS values were significantly lower in the ISPB group during the first 12 h postoperatively than in the control group. No significant differences in mean arterial pressure (MAP) or heart rate (HR) were observed between intraoperative time points in the ISPB group. However, a significant increase in MAP was observed during surgery in the control group (p < 0.001). The incidence of opioid side effects such as nausea, vomiting, and sedation was significantly greater in the control group compared to the ISPB group. ConclusionsInter-semispinal plane block (ISPB) represents an effective analgesic technique and reduces opioid consumption in both intra- and postoperative settings. Moreover, the ISPB could significantly decrease opioid-associated side effects.

Comparison of Binaural Tone Music vs Patient Choice Music vs Midazolam on Perioperative Anxiety in Patients Posted for Surgery Under Spinal Anaesthesia: a Randomized Control Trial.

Background Perioperative anxiety affects patients' hemodynamics by increasing stress levels, leading to delayed recovery. In this study, we compared the anxiety-reducing effect of music (patient choice and binaural tone music) with midazolam for perioperative anxiolysis in patients undergoing surgery under spinal anaesthesia. Methods After obtaining institutional ethical clearance and informed written consent, a total of 225 patients classified as ASAgrades 1 and 2 (American Society of Anesthesiologists) were enrolled and randomised into three groups of 75 patients per group. Group A patients received research-selected music (binaural tone) via noise-cancelling headphones, Group B received intravenous midazolam (minimum of 1 mg to 2 mg maximum) as per clinical judgement, and Group C participants provided patient-preferred music via noise-cancelling headphones. The patient's perioperative anxiety was assessed using a visual analogue anxiety scale at regular time intervals. Results Anxiety scores were significantly reduced in the patient's choice music group (Group C) and binaural tone music group (Group A) as compared to the midazolam group (Group B). Postoperative pain scores were statistically significantly lower in Group C, followed by Group A and Group B. On comparing patient satisfaction scores, using numerical rating scores,96% of patients in Group C achieved excellent scores with a p-value of 0.007. Conclusion Binaural tone music and patient choice music can be suitable alternatives to pharmacological therapies for perioperative anxiolysis.

Efficacy of Dupilumab in Children 6 Months to 11 Years Old With Atopic Dermatitis: A Retrospective Real-World Study in China.

Background: Atopic dermatitis (AD) is a common skin disease that affects patients' quality of life, especially in the pediatric population. Dupilumab has shown good efficacy and safety in the treatment of AD in adolescents and adults, but the real data on younger children using dupilumab are scarce. Objectives: We investigated the doses, efficacy, and safety of dupilumab in children with moderate-to-severe AD aged ≥6 months to 11 years. Methods: This single-center retrospective cohort analysis included dupilumab-treated patients with severe AD under 12 years of age. Primary endpoints included the proportion of Validated Investigator Global Assessment (vIGA) 0/1 achieved and the percentage change from baseline in eczema area and severity index (EASI) and SCORing Atopic Dermatitis (SCORAD) at week 24 (W24). Secondary endpoints were mean change in pruritus numerical rating score (P-NRS) and body surface area (BSA) after W24 of treatment, description of adverse events, and Children's Dermatology Life Quality Index (CDLQI) improvement from baseline in endpoints. Results: Fifty-seven patients were included (mean age 7.2 ± 3.0 years). The primary endpoint (vIGA = 0/1) was achieved by 51 of 57 (89.5%) patients at W24. Significant improvements in EASI, SCORAD, P-NRS, and CDLQI scores were observed from baseline to W24 with dupilumab treatment and remained until W40. In different age groups, the endpoint vIGA achieved 0/1: 95.2% (20/21) of younger children and 88.9% (32/36) of older children. No serious adverse drug reactions were reported. Conclusions: This study aimed to describe the safety and efficacy of dupilumab in pediatric patients and examined differences of efficacy with various doses. The outcomes are comparable with those of existing clinical trials. Phase III Clinical Trial: NCT03346434.

Unicompartmental Knee Arthroplasty Patients Have Lower Joint Awareness and Higher Function at 5 Years Compared to Total Knee Arthroplasties: A Matched Comparison

BackgroundThe purpose of this study was to evaluate postoperative outcomes at minimum 5-year follow-up in patients following unicompartmental knee arthroplasty (UKA) compared to a matched cohort of total knee arthroplasty (TKA) patients. MethodsPatients who had primarily medial compartment osteoarthritis (OA) who met criteria for medial UKA underwent TKA or medial UKA between 2014 and 2015 at a single institution, matched for age, sex, and body mass index. There were 127 UKAs in 120 patients and 118 TKAs in 116 patients included with minimum 5-year follow-up (range, 6 to 8). Mean age was 69 years (range, 59 to 79) and 71 years (range, 62 to 80) in the UKA and TKA groups, respectively (P = .049). ResultsPatients who underwent UKA had significantly higher mean (±SD) Forgotten Joint Scores (87 ± 20 versus 59 ± 34, P < .001); higher Knee Society Scores (88 ± 14 versus 75 ± 21, P < .001); and lower Numeric Pain Rating Scores (0.8 ± 1.6 versus 1.9 ± 2.2, P < .001). Survivorship free from all-cause revision was 96% (95% CI = 93%-99%) and 99% (95% CI = 97%-100%) at 5 years for TKA and UKA, respectively (P = .52). There were 8 both component revisions in the TKA group within 5 years from the date of surgery and 2 UKA conversions to TKA after 5-year follow-up. ConclusionPatients who have medial compartment OA and underwent UKA had significantly lower joint awareness, decreased pain, improved function, and higher satisfaction compared to matched TKA patients at minimum 5-year follow-up while maintaining excellent survivorship.

Riluzole for treating spasticity in patients with chronic traumatic spinal cord injury: Study protocol in the phase ib/iib adaptive multicenter randomized controlled RILUSCI trial.

Satisfactory treatment is often lacking for spasticity, a highly prevalent motor disorder in patients with spinal cord injury (SCI). Low concentrations of riluzole potently reduce the persistent sodium current, the post-SCI increase in which contributes to spasticity. The repurposing of this drug may therefore constitute a useful potential therapeutic option for relieving SCI patients suffering from chronic traumatic spasticity. RILUSCI is a phase 1b-2b trial designed to assess whether riluzole is a safe and biologically effective means of managing spasticity in adult patients with traumatic chronic SCI. In this multicenter double-blind trial, adults (aged 18-65 years) suffering from spasticity after SCI (target enrollment: 90 participants) will be randomly assigned to be given either a placebo or a recommended daily oral dose of riluzole for two weeks. The latter dose will be previously determined in phase 1b of the study by performing double-blind dose-finding tests using a Bayesian continuous reassessment method. The primary endpoint of the trial will be an improvement in the Modified Ashworth Score (MAS) or the Numerical Rating Score (NRS) quantifying spasticity. The secondary outcomes will be based on the safety and pharmacokinetics of riluzole as well as its impact on muscle spasms, pain, bladder dysfunction and quality of life. Analyses will be performed before, during and after the treatment and the placebo-controlled period. To the best of our knowledge, this clinical trial will be the first to document the safety and efficacy of riluzole as a means of reducing spasticity in patients with chronic SCI. The clinical trial, which is already in progress, was registered on the ClinicalTrials.gov website on August 9, 2016 under the registration number NCT02859792. Assistance Publique-Hôpitaux de Marseille.

Health-Related Quality of Life Following Robotic-Assisted or Video-Assisted Lobectomy in Patients With Non-Small Cell Lung Cancer: Results From the RVlob Randomized Clinical Trial

Robot-assisted lobectomy (RAL) is increasingly used as an alternative to video-assisted lobectomy (VAL) for resectable non-small cell lung cancer (NSCLC). However, there is little evidence of any difference in postoperative health-related quality of life (HRQoL) between these two approaches. Is RAL superior to VAL in improving quality of life in patients with resectable NSCLC? We performed a single-center, open-label randomized clinical trial from May 2017 to May 2020 with 320 enrolled patients undergoing RAL or VAL for resectable NSCLC (RVlob trial; NCT03134534). Postoperative pain was evaluated by visual analog score or numeric rating score on postoperative day 1 and at weeks 4, 24, and 48. The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30), EORTC Quality of Life Questionnaire in Lung Cancer (QLQ-LC13), and the European Quality of Life 5 Dimensions (EQ-5D) questionnaire were also administered at weeks 4, 24, and 48 after surgery. One hundred and fifty-seven patients underwent RAL and 163 underwent VAL. The mean pain score of patients after RAL was significantly lower at week 4 (2.097 ± 0.111 vs2.431 ± 0.108; P= .032). QLQ-C30 and QLQ-LC13 summary scores (P > .05) were similar for both RAL and VAL during the first 48weeks of follow-up. HRQoL scores assessed with the EQ-5D questionnaire were also comparable between the two groups (P > .05) during the whole study period. Both RAL and VAL showed satisfactory and comparable HRQoL and postoperative pain up to 48weeks after surgery, despite some minor statistical differences at week4. ClinicalTrials.gov; No.: NCT03134534; URL: www. gov.

Association between history of childbirth and chronic, functionally significant back pain in later life

BackgroundBack pain is more prevalent among women than men. The association with sex could be related to pregnancy and childbirth, unique female conditions. This association has not been thoroughly evaluated.MethodsUsing a retrospective cohort design, we evaluated the relationship between history of childbirth on the prevalence and severity of functionally consequential back pain in 1069 women from a tertiary care pain management clinic. Interactions among preexisting, acute peripartum, and subsequent back pain were evaluated as secondary outcomes among the parous women using logistic and linear regression as appropriate.ResultsThe women who had given birth had a higher risk for functionally significant back pain compared to women who had not given birth (85% vs 77%, p < 0.001, Risk Ratio 1.11 [1.04-1.17]). The association was preserved after correction for age, weight, and race. Back pain was also more slightly severe (Numerical Rating Score for Pain 7[5-8] vs 6[5-7] out of 10, p = 0.002). Women who recalled severe, acute postpartum back pain had a higher prevalence of current debilitating back pain (89% vs 75%, Risk Ratio 1.19 (1.08-1.31), p = 0.001). Twenty-eight percent of acute postpartum back pain never resolved and 40% reported incomplete resolution.ConclusionsA history of pregnancy and childbirth is a risk factor for chronic functionally significant back pain in women. Severe acute postpartum back pain is a risk factor for future disability suggesting that the peripartum period may provide an important opportunity for intervention. Early recognition and management may mitigate future disability.Trial registrationThe study was registered with clinicaltrials.gov as “Association Between Chronic Headache and Back Pain with Childbirth” (NCT04091321) on 16/09/2019 before it was initiated.

Analgesic Efficacy of Erector Spinae Plane Block Versus Transversus Abdominis Plane Block in Laparotomies for Cancer Surgeries

Background: Pain has a wide spectrum of effects on the body and inadequate management of postoperative pain outcomes in multiple physiological and psychological consequences; and increases morbidity. The use of opioid-based analgesia in high doses can have multiple adverse effects including respiratory depression, nausea, and vomiting. Objectives: Our aim was to evaluate the efficacy of analgesic and safety of both techniques (transversus abdominis plane block [TAPB] and erector spinae plane block [ESPB]) in cases having lower abdominal surgery through laparotomy. Materials and Methods: This randomized trial was performed on 62 cases who underwent laparotomy for lower abdominal surgery under general anesthesia were recruited. Subjects were equally distributed into either TAPB or ESPB. The primary outcome was total morphine intake postoperatively for 24 h. Other variables were intraoperative fentanyl consumption, delay to first morphine demand, and intraoperative morphine consumption, the number of patients who needed rescue analgesia by morphine, perioperative heart rate and mean blood pressure, numerical rating score (NRS), postoperative nausea and vomiting, and block-related complications. Results: ESPB patients consumed less total postoperative morphine than the TAPB group (5.35 ± 2.65 vs. 8.52 ± 3.35 mg; P &lt; 0.001). Patients who received ESPB showed less postoperative pain scores and, thus, needed rescue medication after a longer period than the TAPB group (12.50 ± 7.31 h vs. 7.72 ± 5.69 h; P = 0.008). In addition, ESPB patients needed less intraoperative fentanyl doses than TAPB (138.71 ± 35.85 vs. 203.23 ± 34.00 mcg; P &lt; 0.001). ESPB group demonstrated statistically significant lower scores of NRS at rest and at movement. Conclusions: Ultrasound (US)-guided ESPB provides more safe and effective analgesia in lower abdominal surgeries compared with US-guided TAPB.

Comparative efficacy of quadratus lumborum type-II and erector spinae plane block in patients undergoing caesarean section under spinal anaesthesia: a randomised controlled trial

BackgroundQuadratus lumborum and erector spinae plane blocks have been used to provide analgesia in patients undergoing thoracic or abdominal surgeries. Our study compared the analgesic efficacy of the quadratus lumborum type-II block (QLB-II) and the erector spinae plane block (ESPB) in parturients who underwent caesarean section under spinal anaesthesia. MethodsFifty-two patients with comparable demographic profiles were randomised into two groups, QLB-II (n = 26) and ESPB (n = 26). After the surgery, patients received either ultrasound-guided QLB-II or ESPB using 0.25% bupivacaine 0.3 mL/kg. Comparison of analgesic efficacy was in terms of fentanyl consumption (primary outcome), pain scores, incidence of complications in the 24-h postoperative period, and quality of recovery (QoR-15) on postoperative days one and two, and day of discharge. ResultsThere was no significant difference in cumulative number of fentanyl doses (W = 349.000, P = 0.840), numerical rating score at rest (P = 0.648) or with movement (P = 0.520), QoR-15 scores on postoperative day one (P = 0.549), day two (P = 0.927) or day of discharge (P = 0.676). ConclusionWe concluded that patients who underwent QLB-II or ESPB reported similar analgesic efficacy, complications, and quality of recovery in the postoperative period.

Comparison of muscle energy technique and mobilization with movement to reduce pain and improve functional status in subjects with anterior innominate ilio-sacral dysfunction

ObjectiveThis study aimed to compare Muscle energy technique (METs) and Mobilization with movement (MWM) for pain reduction and improving functional status in subjects with anterior innominate iliosacral dysfunction. MethodologyThirty-six patients with anterior innominate iliosacral dysfunction were randomly assigned to both groups. Numeric Pain Rating Scale (NPRS) and Modified Oswestry Disability Index (MODI) were used to measure pain and functional disability. Four weeks of treatment sessions were given to each participant. ResultsThe findings of this study have revealed that statistically, differences were present within and between two groups (p-value <0.05) in the Numeric Pain Rating Score and Modified Oswestry Disability Index. After 4 weeks of treatment, pain intensity decreased and functional ability increased to a greater extent in the MET group, with a mean value of 3.05 ± 0.96 for pain and 23.82 ± 4.39 for modified Oswestry index as compared to the MWM group with a mean value of 4.58 ± 1.06 for pain and 30.29 ± 5.89 for modified Oswestry index in mobilization with movement group. ConclusionThis study concluded that both Muscle Energy Technique and Mobilization with Movement techniques are effective in reducing pain and improving functional ability in patients with Anterior Innominate Iliosacral dysfunction. But when both groups were compared with each other Muscle Energy Techniques were more effective than Mobilization with Movement.

A cost-utility analysis between decompression only and fusion surgery for elderly patients with lumbar spinal stenosis and sagittal imbalance

Lumbar spinal stenosis (LSS) and sagittal imbalance are relatively common in elderly patients. Although the goals of surgery include both functional and radiological improvements, the criteria of correction may be too strict for elderly patients. If the main symptom of patients is not forward-stooping but neurogenic claudication or pain, lumbar decompression without adding fusion procedure may be a surgical option. We performed cost-utility analysis between lumbar decompression and lumbar fusion surgery for those patients. Elderly patients (age > 60 years) who underwent 1–2 levels lumbar fusion surgery (F-group, n = 31) or decompression surgery (D-group, n = 40) for LSS with sagittal imbalance (C7 sagittal vertical axis, C7-SVA > 40 mm) with follow-up ≥ 2 years were included. Clinical outcomes (Euro-Quality of Life-5 Dimensions, EQ-5D; Oswestry Disability Index, ODI; numerical rating score of pain on the back and leg, NRS-B and NRS-L) and radiological parameters (C7-SVA; lumbar lordosis, LL; the difference between pelvic incidence and lumbar lordosis, PI-LL; pelvic tilt, PT) were assessed. The quality-adjusted life year (QALY) and incremental cost-effective ratio (ICER) were calculated from a utility score of EQ-5D. Postoperatively, both groups attained clinical and radiological improvement in all parameters, but NRS-L was more improved in the F-group (p = 0.048). ICER of F-group over D-group was 49,833 US dollars/QALY. Cost-effective lumbar decompression may be a recommendable surgical option for certain elderly patients, despite less improvement of leg pain than with fusion surgery.