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Background We aimed to investigate the compression and ischemic effects of two different tourniquet pressures on tissues during surgery show a clinical difference. Methods Patients aged 18–65 years who underwent foot and ankle surgery and applied a tourniquet in a single center between September 2022 and November 2023 were included in this prospective randomized study. Accordingly, tourniquet pressures were applied as limb occlusion pressure (LOP) + 50 mmHg in group 1 (12 patients) and LOP + 100 mmHg in group 2 (12 patients). The time point at which the femoral nerve motor evoked potential (MEP) decreased by 50%, the time point at which the MEP decreased by 100% for all nerves (femoral, tibial, and deep peroneal), and the time point at which all responses returned after the tourniquet was deflated were identified as the time points for analysis. Results There were no differences in demographic data (age, body mass index, and sex) between the two groups. The mean tourniquet pressure was 191 ± 16 mmHg in Group 1 and 247 ± 21 mmHg in Group 2 ( p  < 0.001). A 50% decrease in the femoral nerve MEP value was observed at an average of 47 min in Group 1 and 34 min in Group 2 ( p  < 0.001). A complete loss of MEP responses for all nerves was observed at an average of 69 min in Group 1 and 56 min in Group 2. After the tourniquet was deflated, all MEP responses returned to baseline values at an average of 8.5 min in Group 1 and 12.6 min in Group 2 ( p  = 0.007). The results showed that lower limb nerve innervation was affected later and returned to normal earlier after deflation of the tourniquet in Group 1 (low tourniquet pressure group). Conclusions The innervations of the lower extremity nerves were affected later in the group in which low tourniquet pressure was applied (average 191 mmHg). Again, in this group (LOP + 50 mmHg), nerve conduction recovered an average of 10 min after deflation and four minutes earlier than in the high tourniquet pressure group. Level of evidence Level I, diagnostic study. Trial registration NCT05926154.

ObjectivesRandomised controlled trial of the effect of a perineural infusion of levobupivacaine on moderate/severe phantom limb pain 6 months after major lower limb amputation.SettingSingle-centre, UK university hospital.ParticipantsNinety patients undergoing above-knee and below-knee amputation for chronic limb threatening ischaemia under general anaesthesia. Exclusion criteria were patients having surgery under neuraxial anaesthesia; inability to operate a patient-controlled analgesia device or complete a Visual Analogue Scale; amputation for trauma or malignancy; or contraindication to levobupivacaine.InterventionsEither levobupivacaine 0.125% or saline 0.9% (10 mL bolus, infusion of 8 mL/hour for 96 hours) via a sciatic or posterior tibial nerve sheath catheter placed under direct vision during surgery.Primary and secondary outcome measuresThe primary outcome measure was the presence of phantom limb pain, residual limb pain and phantom limb sensations up to 6 months after amputation. Secondary outcome measures included early postoperative pain and morphine requirements after surgery.ResultsData from 81 participants were analysed; 6-month follow-up data were available for 62 patients. Pain and morphine requirements varied widely before and after amputation in both groups. The incidences of moderate/severe phantom limb pain, residual limb pain and phantom limb sensations were low from 6 weeks with no significant differences between groups in phantom limb pain at rest (OR 0.56, 95% CI 0.14 to 2.14, p=0.394) or movement (OR 0.58, 95% CI 0.15 to 2.21, p=0.425) at 6 months. Early postoperative pain scores were low in both groups with no between-group differences in residual limb pain or phantom limb sensations (rest or movement) at any time point. High postoperative morphine consumption was associated with worsening phantom limb pain both at rest (−17.51, 95% CI −24.29 to −10.74; p<0.001) and on movement (−18.54, 95% CI −25.58 to −11.49; p<0.001). The incidence of adverse effects related to the study was low in both groups: postoperative nausea, vomiting and sedation scores were similar, and there were no features of local anaesthetic toxicity.ConclusionsLong-term phantom limb pain, residual limb pain and phantom limb sensations were not reduced significantly by perineural infusion of levobupivacaine, although the study was underpowered to show significant differences in the primary outcome. The incidence of phantom limb pain was lower than previously reported, possibly attributable to frequent assessment and early intervention to identify and treat postoperative pain when it occurred. There were large variations in postoperative pain scores, high requirements for analgesics before and after surgery and some problems maintaining recruitment and long -term follow-up. Knowledge of these potential problems should inform future research in this group of patients. Further work should investigate the association between perioperative morphine requirements and late phantom limb pain.Trial registration numbersEudraCT 2007-000619-27; ISRCTN68691928.

Background and ObjectivesLocal infiltration analgesia (LIA) reduces pain after total knee arthroplasty without the motor blockade associated with epidural analgesia or femoral nerve block. However, the duration and efficacy of LIA are not sufficient. A saphenous nerve block, in addition to single-dose LIA, may improve analgesia without interfering with early mobilization.MethodsForty patients were included in this double-blind randomized controlled trial. All patients received spinal anesthesia for surgery and single-dose LIA during the operation. An ultrasound-guided saphenous nerve catheter was placed postoperatively in the adductor canal at midthigh level. Patients were randomized into 2 groups to receive 15-mL boluses of either ropivacaine 7.5 mg/mL or saline twice daily for 2 postoperative days.ResultsWorst pain scores during movement on the day of surgery were significantly lower in the ropivacaine group (median [range] visual analog scale, 3 [0–7] vs 5.5 [0–10]; P < 0.050), as well as pain at rest (visual analog scale, 2 [0–8] vs 4 [0–8]; P = 0.032). Breakthrough pain occurred later in the ropivacaine group (10.5 [range, 0.5–48] hours vs 3.4 [range, 0.5–24] hours; P = 0.011). All patients in the ropivacaine group were able to ambulate on the day of surgery versus 13 patients in the control group (P = 0.004). Fewer patients had sleep disturbance on the first postoperative night in the ropivacaine group (P = 0.038). We found no differences in morphine consumption.ConclusionsThe combination of a saphenous nerve block with single-dose LIA offered better pain relief on the day of surgery than LIA alone.

ObjectivesTo determine the feasibility of undertaking a randomised controlled effectiveness trial evaluating the use of a perineural catheter (PNC) after major lower limb amputation with postoperative pain as the primary outcome.DesignRandomised controlled feasibility trial.SettingTwo vascular Centres in South Wales, UK.Participants50 patients scheduled for major lower limb amputation (below or above knee) for complications of peripheral vascular disease.InterventionsThe treatment arm received a PNC placed adjacent to the sciatic or tibial nerve at the time of surgery, with continuous infusion of levobupivacaine hydrochloride 0.125% for up to 5 days. The control arm received neither local anaesthetic nor PNC. Both arms received usual perioperative anaesthesia and postoperative analgesia.Primary and secondary outcome measuresThe primary outcomes were the proportion of eligible patients who were randomised and the proportion of recruited patients who provided primary effectiveness outcome data. Secondary outcomes were: the proportion of recruited patients reaching 2 and 6 month follow-up and supplying pain data; identification of key cost drivers; development of an economic analysis framework for a future effectiveness trial; identification of barriers to recruitment and site set-up; and identification of the best way to measure postoperative pain.ResultsSeventy-six of 103 screened patients were deemed eligible over a 10 month period. Fifty (64.5%) of these patients were randomised, with one excluded in the perioperative period. Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation. Attrition rates were high; 18 patients supplied data at 6 month follow-up. Costs were dominated by length of hospital stay. Patients and healthcare professionals reported that trial processes were acceptable.ConclusionsRecruitment of patients into a trial comparing PNC use to usual care after major lower limb amputation with postoperative pain measured on a 4-point verbal rating scale is feasible. Evaluation of longer-term symptoms is difficult.Trial registration numberISRCTN: 85 710 690. EudraCT: 2016-003544-37.

Background Repetitive transcranial magnetic stimulation (rTMS) has been investigated as a new tool in neurological rehabilitation of individuals with spinal cord injury (SCI). However, due to the inconsistent results regarding the effects of rTMS in people with SCI, a randomized controlled double-blind crossover trial is needed to clarify the clinical utility and to assess the effect size of rTMS intervention in this population. Therefore, this paper describes a study protocol designed to investigate whether the use of rTMS can improve the motor and sensory function, as well as reduce spasticity in patients with incomplete SCI. Methods A double-blind randomized sham-controlled crossover trial will be performed by enrolling 20 individuals with incomplete SCI. Patients who are at least six months post incomplete SCI (aged 18–60 years) will be recruited through referral by medical practitioners or therapists. Individuals will be randomly assigned to either group 1 or group 2 in a 1:1 ratio, with ten individuals in each group. The rTMS protocol will include ten sessions of high-frequency rTMS (5 Hz) over the bilateral lower-limb motor area positioned at the vertex (Cz). Clinical evaluations will be performed at baseline and after rTMS active and sham. Discussion rTMS has produced positive results in treating individuals with physical impairments; thus, it might be promising in the SCI population. The results of this study may provide new insights to motor rehabilitation thereby contributing towards the better usage of rTMS in the SCI population. Trial registration ClinicalTrials.gov, NCT02899637 . Registered on 25 August 2016.

Objective: To investigate the effect of decompression of nerves in the lower extremity in patients with painful diabetic polyneuropathy on static balance using a sensitive pressure mat system. Design: Non-blinded randomized controlled trial. Setting: Single center study performed at the University Medical Center Utrecht between 2010-2013. Subjects: Patients with painful diabetic polyneuropathy assessed with the Diabetic Neuropathy Symptom score and Diabetic Neuropathy Examination between 18-90 years. Exclusion criteria were: physical problems leading to instability, BMI>35 kg/m2, ankle fractures in history, amputations proximal to the tarsometatarsal joints, active foot ulcer(s), severe occlusive peripheral vascular diseases. Intervention: Unilateral surgical nerve decompression at four sites in the lower extremity, the contralateral limb was used as control (within-patient comparison), with one year follow-up. Main measures: Preoperatively and 6 and 12 months postoperatively, weight bearing and five variables of sway of the center of pressure were measured with a pressure mat with eyes open and eyes closed. T-test was used for evaluation of postoperative results. Results: Thirty-nine Patients met inclusion criteria and were enrolled for stability testing. Postoperatively no significant differences for sway variables and weight bearing were seen compared to preoperatively measurements. Conclusions: There is no evidence that surgical decompression of nerves of the lower extremity influences stability within one year after surgery in patients with painful diabetic polyneuropathy.

IntroductionIncreasing evidence supports the utilisation of functional electrical stimulation (FES) to improve gait following stroke; however, few studies have focused exclusively on its use in the convalescent phase. In addition, its efficacy in patients with a non-Western life style has not been evaluated.Methods and analysisThis is a randomised, controlled, open-label multicentre study, comparing rehabilitation with and without FES. The purpose of our study is to test the hypothesis that the FES system improves walking ability in Japanese patients with hemiplegia during the convalescent phase. Two hundred patients aged 20–85 years who had an initial stroke ≤6 months prior to the enrolment, are in a convalescent phase (after the end of acute phase treatment, within 6 months after the onset of stroke) with functional ambulation classification 3 or 4 and have a hemiplegic gait disorder (drop foot) due to stroke have been recruited from 21 institutions in Japan. The patients are randomised in 1:1 fashion to usual gait rehabilitation or rehabilitation using FES (Walkaide). The trial duration is 8 weeks, and the primary outcome measured will be the change in maximum distance from baseline to the end of the trial, as measured with the 6 min walk test (6-MWT). The 6-MWT is performed barefoot, and the two treatment groups are compared using the analysis of covariance.Ethics and disseminationThis study is conducted in accordance with the principles of the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects and is approved by the ethics committee of all participating institutions. The published results will be disseminated to all the participants by the study physicians.Trial registration numberThe University Hospital Medical Information Network-Clinical Studies Registry (UMIN000020604).

Background: The estimated prevalence of lumbar radiculopathy has been described as 9.8 per 1,000 cases of low back pain. There are various surgical and nonsurgical modalities for treating lumbar disc herniation or radicular pain, including epidural injections. Epidural injection administration routes include transforaminal, interlaminar, and caudal approaches. The transforaminal approach requires the smallest volume to reach the primary site of pathology. Systematic reviews have yielded highly variable results, but a recent systematic review showed no significant difference among the 3 approaches. Study Design: A randomized, controlled, double blind, active control trial. Setting: An interventional pain management practice, a private specialty referral center in the United States. Objectives: To assess the effectiveness of transforaminal epidural injections of local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis. Methods: One hundred twenty patients were randomly assigned to 2 groups: Group I received 1.5 mL of 1% preservative-free lidocaine, followed by 0.5 mL of sodium chloride solution. Group II received 1% lidocaine, followed by 3 mg, or 0.5 mL of betamethasone. The sodium chloride solution and betamethasone were either clear liquids or were provided in opaquecovered syringes. Outcomes Assessment: The primary outcome measure was significant improvement (at least 50%) measured by the average Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake. Results: At 2 years there was significant improvement in all participants in 65% who received local anesthetic alone and 57% who received local anesthetic and steroid. When separated into non-responsive and responsive categories based on initial relief of at least 3 weeks with 2 procedures, significant improvement (at least 50% improvement in pain and function) was seen in 80% in the local anesthetic group and 73% in the local anesthetic with steroid group. Limitations: Presumed limitations of this evaluation include the lack of a placebo group. Conclusion: Transforaminal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the lack of superiority of steroids compared with local anesthetic at 2-year follow-up. Key words: Chronic low back pain, transforaminal epidural injections, disc herniation, radiculitis, lower extremity pain, local anesthetic, steroids

Background It is hypothesized that locomotion is achieved by means of rhythm generating networks (central pattern generators) and muscle activation generating networks. This modular organization can be partly identified from the analysis of the muscular activity by means of factorization algorithms. The activity of rhythm generating networks is described by activation signals whilst the muscle intervention generating network is represented by motor modules (muscle synergies). In this study, we extend the analysis of modular organization of walking to the case of robot-aided locomotion, at varying speed and body weight support level. Methods Non Negative Matrix Factorization was applied on surface electromyographic signals of 8 lower limb muscles of healthy subjects walking in gait robotic trainer at different walking velocities (1 to 3km/h) and levels of body weight support (0 to 30%). Results The muscular activity of volunteers could be described by low dimensionality (4 modules), as for overground walking. Moreover, the activation signals during robot-aided walking were bursts of activation timed at specific phases of the gait cycle, underlying an impulsive controller, as also observed in overground walking. This modular organization was consistent across the investigated speeds, body weight support level, and subjects. Conclusions These results indicate that walking in a Lokomat robotic trainer is achieved by similar motor modules and activation signals as overground walking and thus supports the use of robotic training for re-establishing natural walking patterns.

BackgroundInconsistent nomenclature and anatomical descriptions of regional anesthetic techniques hinder scientific communication and engender confusion; this in turn has implications for research, education and clinical implementation of regional anesthesia. Having produced standardized nomenclature for abdominal wall, paraspinal and chest wall regional anesthetic techniques, we aimed to similarly do so for upper and lower limb peripheral nerve blocks.MethodsWe performed a three-round Delphi international consensus study to generate standardized names and anatomical descriptions of upper and lower limb regional anesthetic techniques. A long list of names and anatomical description of blocks of upper and lower extremities was produced by the members of the steering committee. Subsequently, two rounds of anonymized voting and commenting were followed by a third virtual round table to secure consensus for items that remained outstanding after the first and second rounds. As with previous methodology, strong consensus was defined as ≥75% agreement and weak consensus as 50%–74% agreement.ResultsA total of 94, 91 and 65 collaborators participated in the first, second and third rounds, respectively. We achieved strong consensus for 38 names and 33 anatomical descriptions, and weak consensus for five anatomical descriptions. We agreed on a template for naming peripheral nerve blocks based on the name of the nerve and the anatomical location of the blockade and identified several areas for future research.ConclusionsWe achieved consensus on nomenclature and anatomical descriptions of regional anesthetic techniques for upper and lower limb nerve blocks, and recommend using this framework in clinical and academic practice. This should improve research, teaching and learning of regional anesthesia to eventually improve patient care.