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The effect of local anaesthetic wound infiltration on chronic pain after lower limb joint replacement: a protocol for a double-blind randomised controlled trial.

ABSTRACT: For the majority of patients with osteoarthritis (OA), joint replacement is a successful intervention for relieving chronic joint pain. However, between 10-30% of patients continue to experience chronic pain after joint replacement. Evidence suggests that a risk factor for chronic pain after joint replacement is the severity of acute post-operative pain. The aim of this randomised controlled trial (RCT) is to determine if intra-operative local anaesthetic wound infiltration additional to a standard anaesthesia regimen can reduce the severity of joint pain at 12-months after total knee replacement (TKR) and total hip replacement (THR) for OA.300 TKR patients and 300 THR patients are being recruited into this single-centre double-blind RCT. Participants are recruited before surgery and randomised to either the standard care group or the intervention group. Participants and outcome assessors are blind to treatment allocation throughout the study. The intervention consists of an intra-operative local anaesthetic wound infiltration, consisting of 60 mls of 0.25% bupivacaine with 1 in 200,000 adrenaline. Participants are assessed on the first 5 days post-operative, and then at 3-months, 6-months and 12-months. The primary outcome is the WOMAC Pain Scale, a validated measure of joint pain at 12-months. Secondary outcomes include pain severity during the in-patient stay, post-operative nausea and vomiting, satisfaction with pain relief, length of hospital stay, joint pain and disability, pain sensitivity, complications and cost-effectiveness. A nested qualitative study within the RCT will examine the acceptability and feasibility of the intervention for both patients and healthcare professionals.Large-scale RCTs assessing the effectiveness of a surgical intervention are uncommon, particularly in orthopaedics. The results from this trial will inform evidence-based recommendations for both short-term and long-term pain management after lower limb joint replacement. If a local anaesthetic wound infiltration is found to be an effective and cost-effective intervention, implementation into clinical practice could improve long-term pain outcomes for patients undergoing lower limb joint replacement.Current Controlled Trials ISRCTN96095682.

SUBMITTER: Wylde V

PROVIDER: S-EPMC3056874 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature

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The effect of local anaesthetic wound infiltration on chronic pain after lower limb joint replacement: a protocol for a double-blind randomised controlled trial.

Wylde Vikki V Gooberman-Hill Rachael R Horwood Jeremy J Beswick Andrew A Noble Sian S Brookes Sara S Smith Alison J AJ Pyke Mark M Dieppe Paul P Blom Ashley W AW

BMC musculoskeletal disorders 20110226

<h4>Background</h4>For the majority of patients with osteoarthritis (OA), joint replacement is a successful intervention for relieving chronic joint pain. However, between 10-30% of patients continue to experience chronic pain after joint replacement. Evidence suggests that a risk factor for chronic pain after joint replacement is the severity of acute post-operative pain. The aim of this randomised controlled trial (RCT) is to determine if intra-operative local anaesthetic wound infiltration ad ...[more]

PMID: 21352559

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Project description: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.

Project description:BackgroundPain after major lower limb amputation for peripheral arterial disease (PAD) is a significant problem. A perineural catheter (PNC) can be placed adjacent to the major nerve at the time of amputation with a continuous local anaesthetic infusion given postoperatively to try and reduce pain. Although low-quality observational data suggest that PNC usage reduces postoperative opioid requirements, there are limited data regarding its effect on pain. The aim of PLACEMENT is to explore the feasibility of running an effectiveness trial to assess the impact of a PNC with continuous local anaesthetic infusion, inserted at the time of amputation, on short and medium-term postoperative outcomes.Methods/designFifty patients undergoing a major lower limb amputation (below or above the knee) for PAD will be recruited from two centres. Patients will be randomised in a 1:1 ratio to receive standard postoperative analgesia, with or without insertion of a PNC and local anaesthetic infusion for the first 5 postoperative days. Outcome data will be captured for the first 5 days, including pain scores (primary outcome, captured three times a day), opioid use, nausea or vomiting, itching, dizziness and complications. Patients will be contacted 2 and 6 months after surgery to assess quality of life, phantom limb pain, chronic stump pain and total healthcare costs. Semi-structured interviews will be conducted with at least 10 patients (dependent on saturation of analytic themes on preliminary coding) purposefully sampled to achieve variation in site and study arm. Interviews will explore patients' perception of post-amputation pain and its treatment, and experience of study processes. Semi-structured interviews with 5-10 health professionals will explore feasibility, fidelity, and acceptability of the study. Data from this pilot will be used to assess feasibility of, and estimate parameters to calculate the sample size for an effectiveness trial. Full ethical approval has been granted (Wales Research Ethics Committee 3 reference number 16/WA/0353).DiscussionPLACEMENT will be the first study to explore the feasibility of running an effectiveness trial on PNC usage for postoperative pain in amputees, and provide parameters to calculate the appropriate sample size for this study.Trial registrationISRCTN.com, ISRCTN85710690 . Registered on 21 October 2016. European Clinical Trials Database (EudraCT), 2016-003544-37. Registered on 24 August 2016.

Project description:IntroductionOver 16 000 mastectomies are performed in England and Wales annually. Acute postoperative pain and nausea are common. The most frequently occurring long-term complications are chronic pain (up to 50%) and reduced shoulder function (reported at 35%). Regional techniques that improve acute postoperative pain relief may reduce the incidence of these complications. This study assesses the effectiveness of a 24-hour continuous local anaesthetic in the subpectoral plane in improving postoperative pain and quality of life in patients undergoing mastectomy.Methods and analysisThis is a randomised, double blind, placebo-controlled, two-centre, parallel group trial in women undergoing mastectomy with or without axillary involvement. One hundred and sixty participants will be randomised in a 1:1 ratio to receive either 0.25% levobupivacaine or 0.9% saline by subpectoral infusion postoperatively for 24 h. All participants will be provided with an intravenous morphine patient-controlled analgesia (PCA) system. Participants will be followed-up for 24 h in hospital and at approximately 14 days and 6 months postoperatively. Joint primary outcome measures are total morphine consumption and total pain score (captured via patient-recorded visual analogue scale (VAS) 4 hourly) during the first 24 h postoperatively. Primary statistical analysis of total pain is based on the area under the curve of pain versus time graph. Secondary outcomes include PCA attempts in first 24 h; VAS pain scores and shoulder function by goniometry at 24 h, 14 days (approximately) and 6 months; Verbal Rating Scale pain scores in first 24 h; Brief Pain Inventory and Oxford Shoulder Score at 6 months; duration of hospital stay; incidence of postoperative nausea and vomiting; cost-effectiveness.Ethics and disseminationThe study is approved by the South West England Research Ethics Committee (12/SW/0149).Resultswill be published in a peer-reviewed journal and presented at local, national and international scientific meetings.Trial registrationISRCTN46621916. EudraCT 2011-005775-16.

Project description:BackgroundLocal anaesthetic infiltration is widely used to reduce pain after laparoscopic cholecystectomy (LC). This trial evaluated the effect of depth of local anaesthetic infiltration on postoperative pain reduction after LC.MethodsPatients undergoing elective LC between March 2018 and February 2019 were randomized into no infiltration, subcutaneous infiltration, and rectus sheath infiltration using bupivacaine. The primary outcome was 24-h postoperative cumulative morphine use, and the secondary outcomes were mean 24-h Numerical Rating Scale (NRS) for pain, and nausea, and vomiting. Subgroups were compared and multivariable analyses were performed.ResultsOut of 170 eligible patients, 162 were selected and 150 patients were analysed: 48 in the no-infiltration group, 50 in the subcutaneous infiltration group, and 52 in the rectus sheath infiltration group. The groups had similar clinical features, although mean BMI was higher in the subcutaneous infiltration group (P = 0.001). The 24-h cumulative morphine use in the rectus sheath infiltration group was significantly lower than in the no-infiltration group (P = 0.043), but no difference was observed between the subcutaneous infiltration and no-infiltration groups (P = 0.999). One hour after surgery, the rectus sheath infiltration group had a significantly lower NRS score than the no-infiltration and subcutaneous infiltration groups respectively (P = 0.006 and P = 0.031); however, the score did not differ among the three groups at any of the time points from 2 h after the surgery. The incidence of nausea or vomiting was comparable among the three groups. Multivariable analysis documented that a lower dose of morphine use was associated with rectus sheath infiltration (P = 0.004) and diabetes (P = 0.001); whereas, increased morphine use was associate with age (P = 0.040) and a longer duration of surgery (P = 0.007).ConclusionsLocal anaesthetic infiltration into the rectus sheath reduced postoperative cumulative morphine use and the immediate NRS score in patients undergoing LC; however, the pain scores were comparable 2 h after surgery.Registration numberTCTR20201103002 (http://www.thaiclinicaltrials.org).

Dataset Information

The effect of local anaesthetic wound infiltration on chronic pain after lower limb joint replacement: a protocol for a double-blind randomised controlled trial.

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The effect of local anaesthetic wound infiltration on chronic pain after lower limb joint replacement: a protocol for a double-blind randomised controlled trial.

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