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Study protocol for a double blind, randomised, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy: SUB-pectoral Local anaesthetic Infusion following MastEctomy (SUBLIME) study.

ABSTRACT: Over 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.This 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.The study is approved by the South West England Research Ethics Committee (12/SW/0149).will be published in a peer-reviewed journal and presented at local, national and international scientific meetings.ISRCTN46621916. EudraCT 2011-005775-16.

SUBMITTER: Langford R

PROVIDER: S-EPMC4179566 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Study protocol for a double blind, randomised, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy: SUB-pectoral Local anaesthetic Infusion following MastEctomy (SUBLIME) study.

Langford R R Brown I I Vickery J J Mitchell K K Pritchard C C Creanor S S

BMJ open 20140930 9

<h4>Introduction</h4>Over 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 improvi ...[more]

PMID: 25270861

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Project description:BackgroundImplant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and more recently, prepectoral techniques being introduced. These muscle-sparing techniques may reduce postoperative pain, avoid implant animation and improve cosmetic outcomes and have been widely adopted into practice. Although small observational studies have failed to demonstrate any differences in the clinical or patient-reported outcomes of prepectoral or subpectoral reconstruction, high-quality comparative evidence of clinical or cost-effectiveness is lacking. A well-designed, adequately powered randomised controlled trial (RCT) is needed to compare the techniques, but breast reconstruction RCTs are challenging. We, therefore, aim to undertake an external pilot RCT (Best-BRA) with an embedded QuinteT Recruitment Intervention (QRI) to determine the feasibility of undertaking a trial comparing prepectoral and subpectoral techniques.Methods and analysisBest-BRA is a pragmatic, two-arm, external pilot RCT with an embedded QRI and economic scoping for resource use. Women who require a mastectomy for either breast cancer or risk reduction, elect to have an IBBR and are considered suitable for both prepectoral and subpectoral reconstruction will be recruited and randomised 1:1 between the techniques.The QRI will be implemented in two phases: phase 1, in which sources of recruitment difficulties are rapidly investigated to inform the delivery in phase 2 of tailored interventions to optimise recruitment of patients.Primary outcomes will be (1) recruitment of patients, (2) adherence to trial allocation and (3) outcome completion rates. Outcomes will be reviewed at 12 months to determine the feasibility of a definitive trial.Ethics and disseminationThe study has been approved by the National Health Service (NHS) Wales REC 6 (20/WA/0338). Findings will be presented at conferences and in peer-reviewed journals.Trial registration numberISRCTN10081873.

Project description:BackgroundPostmastectomy breast reconstruction techniques differentially influence patient-reported physical and psychosocial well-being. Objective measures of shoulder biomechanics, which are uniquely influenced by reconstruction technique, may provide insight into the influence of reconstruction technique on patient-reported outcomes.MethodsRobot-assisted measures of shoulder strength and stiffness, and five validated patient-reported outcomes surveys were obtained from 46 women who had undergone mastectomy and a combined latissimus dorsi flap plus subpectoral implant, subpectoral implant, or DIEP flap breast reconstruction. Mediation analyses examined the role of functional shoulder biomechanics as a mediator between reconstruction technique and patient-reported outcomes.ResultsReconstruction technique affected shoulder biomechanics, with latissimus dorsi flap plus subpectoral implant patients exhibiting reduced shoulder strength and stiffness compared with subpectoral implant and DIEP flap patients. Increasing external rotation strength was predictive of improved upper extremity function (p = 0.04). Increasing shoulder stiffness while at rest was predictive of worsened upper extremity function (p = 0.03). Increasing shoulder stiffness at rest and during contraction was indicative of worsened psychosocial well-being (all p ≤ 0.02). Reconstruction technique did not predict survey scores of function directly, or when mediated by functional shoulder biomechanics.ConclusionsIn the current cohort, latissimus dorsi plus subpectoral implant breast reconstructions significantly reduced shoulder strength and stiffness when compared with the other techniques. In addition, objective measures of shoulder biomechanics were predictive of patient-reported physical and psychosocial well-being. The results emphasize the need for improved perioperative screening for shoulder functional deficits in patients undergoing breast reconstruction.Clinical quesiton/level of evidenceTherapeutic, II.

Project description:BackgroundInflammatory response is one of the key components of pain perception. Continuous infusion (CWI) of local anesthetics has been shown to be effective in controlling pain and reducing postoperative morphine consumption, but the effect of adding a potent anti-inflammatory drug (such as a steroid) has never been addressed. In our study, we want to investigate the effect of CWI with local anesthetic + methylprednisolone on acute and persistent pain, correlating clinical data with biomarkers of inflammation and genetic background.Methods/designAfter approval by their institutional review board, three hospitals will enroll 120 patients undergoing major abdominal surgery in a randomized, double-blind, phase III study. After a 24-h CWI of ropivacaine 0.2 % + methylprednisolone 1 mg/kg, patients will be randomly assigned to receive either ropivacaine + steroid or placebo for the next 24 h. Then, patient-controlled CWI with only ropivacaine 0.2 % or placebo (according to the group of randomization) is planned after 48 h up to 7 days (bolus 10 ml, lock-out 1 h, maximum dose of 40 ml in 4 h). Morphine equivalent consumption up to 7 days will be analyzed, together with any catheter- or drug-related side effect. Persistent post-surgical pain (PPSP) incidence will also be investigated. Our primary endpoint is analgesic consumption in the first 7 days after surgery; we will evaluate, as secondary endpoints, any catheter- or drug-related side effect, genotype/phenotype correlations between some polymorphisms and postoperative outcome in terms of morphine consumption, development of the inflammatory response, and incidence of PPSP. Finally, we will collect, in a subgroup of patients, wound exudate samples by micro-dialysis, blood samples, and urine samples up to 72 h to investigate local and systemic inflammation and oxidative stress.DiscussionThis is a phase III trial to evaluate the safety and efficacy of wound infusion with steroid and local anesthetic. The study is aimed also to evaluate how long this infusion has to be maintained in order to maximize effectiveness. Our data are intended to quantify the amount of ropivacaine and methylprednisolone needed by patients undergoing major abdominal surgery, to be stored in a new nanotechnology device for sustained pain treatment after surgery. We also aim to clarify the roles of inflammatory response, oxidative stress, and genetic background on postoperative and persistent pain after major abdominal surgery.Trial registrationThe trial was registered on ClinicalTrials.gov ( NCT02002663 ) on 24 Oct. 2013.

Project description:IntroductionThe emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast implant above (prepectoral) or below (subpectoral) the pectoralis major muscle or by using the patients' own tissue (autologous reconstruction). The optimal positioning of the implant prepectoral or subpectoral is currently not clear. Subpectoral implant-based breast reconstruction (IBBR) is still standard care in many countries, but prepectoral IBBR is increasingly performed. This heterogeneity in breast reconstruction practice is calling for randomised clinical trials (RCTs) to guide treatment decisions.Methods and analysisInternational, pragmatic, multicentre, randomised, superiority trial. The primary objective of this trial is to test whether prepectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being (chest) compared with subpectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of breast cancer. Secondary objectives will compare prepectoral versus subpectoral IBBR in terms of safety, QoL and patient satisfaction, aesthetic outcomes and burden on patients. Total number of patients to be included: 372 (186 per arm).Ethics and disseminationThis study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained for the lead investigator's site by the Ethics Committee 'Ethikkommission Nordwest- und Zentralschweiz' (2020-00256, 26 March 2020). The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs and good publication practice. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories adhering to the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles.Trial registration numberNCT04293146.

Project description:BackgroundMany types of regional nerve blocks have been used during anesthesia for modified radical mastectomy. In recent years, the use of pectoral nerve (PECS) block has gained importance in postoperative analgesia, but there are still controversies regarding its efficacy. There is especially no consensus on the optimal type of PECS block to be used. Herein, we attempt to evaluate the analgesic efficacy of the PECS block after radical mastectomy.MethodsWe searched PubMed, EMBASE, and the Cochrane library for randomized controlled trials (RCTs) for studies regarding PECS versus general anesthesia (GA) that were published prior to May 31, 2018. Outcome measures such as intra- and postoperative consumption of opioids, postoperative nausea and vomiting (PONV), need for postoperative rescue analgesia, and pain scores were analyzed. After quality evaluation and data extraction, a meta-analysis was performed using Review Manager 5.3 software, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was used for rating the quality of evidence.ResultsA total of 8 RCTs and 2 cohort studies involving 993 patients were eligible. Compared with the GA group, the PECS block group effectively reduced the intraoperative and postoperative use of opioid drugs, incidence of PONV, need for postoperative rescue analgesia, and pain scores within 0 to 6?hours after surgery. However, subgroup analysis showed that PECS I block did not have a significant advantage in reducing the intra- and postoperative consumption of opioids. Results for each outcome indicator were confirmed as having a high or moderate level of evidence.ConclusionsEven considering the limitations (evaluations of efficacy in different age groups and for chronic pain were not carried out) of this meta-analysis, it can be concluded that the PECS II block is an effective anesthetic regimen in modified radical mastectomy that can effectively reduce the intra- and postoperative consumption of opioids, postoperative PONV, and the need for postoperative rescue analgesia and can alleviate early pain (0-6?hours) after surgery.

Dataset Information

Study protocol for a double blind, randomised, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy: SUB-pectoral Local anaesthetic Infusion following MastEctomy (SUBLIME) study.

Publications

Study protocol for a double blind, randomised, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy: SUB-pectoral Local anaesthetic Infusion following MastEctomy (SUBLIME) study.

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