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

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.

Evaluation of postoperative pain in patients undergoing modified radical mastectomy with pectoralis or serratus-intercostal fascial plane blocks

“…No study has directly compared the efficacy of these two blocks in terms of pectoral pain, shoulder or axillary pain, and shoulder mobility after MRM, which is important to promote early physiotherapy to avoid long-term complications like lymphedema, axillary web syndrome (AWS), or shoulder immobility [16]. There was a study protocol that proposed to include shoulder mobility as a parameter in their study, including chest blocks, but to date, no data has been made available [17].…”

The Physiotherapy Intervention for Shoulder Pain in Patients Treated for Breast Cancer: Systematic Review

“…Finally, chronic pain occurs in a proportion of up to 50% of patients six months after surgery [23]. Breast cancer survivors with persistent breast pain have significantly high levels of depressive symptoms, increased apprehension of pain, and increased anxiety as compared to patients who do not have persistent breast pain or women who have no history of cancer [24]. Inadequately managed postoperative pain is a relevant risk factor in chronic pain syndrome.…”