Title: A double-blind randomised placebo controlled trial of subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy
Funder: Department of Health (England)

Abstract: Background There are about 18000 mastectomy operations in the UK each year. Intravenous morphine is the mainstay of post-operative analgesia but has significant side effects including drowsiness and vomiting. The use of local anaesthetic for post-operative pain varies according to surgical preference. We have been using sub-pectoral catheters for local anaesthetic infusion in some of our patients over the last 2 years and believe it may provide superior analgesia, with possible benefits to early and late shoulder mobility and chronic pain rates (seen in 40% of patients). We intend to test the efficacy of 48-hour local anaesthetic infusion through sub-pectoral catheters compared to standard practice following mastectomy in a randomised double-blinded placebo controlled study. Aims Using a double-blind randomised controlled trial, we aim to establish whether a 48-hour post-operative continuous infusion of local anaesthetic via a sub-pectoral catheter provides superior post-operative analgesia compared to standard practice in patients undergoing mastectomy with or without axillary surgery. We will compare opiate use and pain scores following surgery and assess chronic pain at 6 months. We will compare arm movement and shoulder function scores in the immediate post-operative period and at 6 months. We will assess post-operative nausea, vomiting, length of hospital stay and quality of life and document any complications associated with the use of this technique. We will assess cost effectiveness in a full economic evaluation. Plan of Investigation Patients presenting for mastectomy surgery will be invited to participate. They will be stratified according to the degree of axillary surgery and randomised to the local anaesthetic (LA) or placebo (NS) group. During surgery, all patients will have a sub-pectoral catheter sited under direct vision. Post-operatively, the LA group will receive an infusion of 0.25% levobupivicaine at 5ml/hr via the catheter. The NS group will receive 0.9% saline at the same rate. All patients will have a morphine patient controlled analgesia (PCA) device. Opiate use, pain scores, nausea, vomiting, patient satisfaction and length of hospital stay will be recorded. Arm mobility and function will be assessed at baseline, 14 days and 6 months after surgery. The economic evaluation will estimate cost per QALY. Potential Impact Mastectomy is a relatively common operation but pain management following surgery presents well-recognised challenges. Sub-pectoral local anaesthetic infusion is a relatively low cost intervention and the technique is readily mastered. If our study indicates a beneficial effect for mastectomy patients it would be straightforward to implement across the NHS resulting in superior analgesia for thousands of women every year. Additional benefits may be seen in terms of reduced chronic pain rate and improved shoulder movement and function. Potential cost savings may come from a reduction in the need to manage these complications, with less reliance on medication for chronic pain, reduced use of chronic pain services and physiotherapy.


Research activity codes: 6.4 SURGERY;6.1 PHARMACEUTICALS
Health categories: CANCER AND NEOPLASMS