A randomised, double blind, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy.

INTERVENTION: Trade Name: Levobupivacaine Product Name: Levobupivacaine Pharmaceutical Form: Solution for injection INN or Proposed INN: Levobupivacaine Other descriptive name: Chirocaine Concentration unit: % percent Concentration type: equal Concentration number: 0.25‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Infiltration CONDITION: Post‐operative pain following mastectomy surgery ; MedDRA version: 14.1 Level: PT Classification code 10024758 Term: Local anaesthesia System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: Does a continuous infusion of levobupivacaine, a local anaesthetic, through a small tube placed at the time of surgery beneath the muscle on the chest wall, reduce post‐operative pain over the initial 24 hours following mastectomy surgery? Primary end point(s): The joint primary outcomes are:‐ i) Total morphine consumption (mg) in the first 24 hours following surgery, including all morphine given in the Recovery Unit and cumulative PCA use as recorded by the PCA device. ii) Total pain over the first 24 hours following surgery, as defined by measurement of the area‐under‐the‐curve of each participant’s self‐reported pain scores at rest, measured using a visual analogue scale (VAS). Recordings will be made prior to leaving the Recovery Unit and at four hourly intervals throughout the first 24 hours following surgery. Secondary Objective: Does a 24 hour continuous infusion of the local anaesthetic levobupivacaine into a tissue plane beneath the chest muscle reduce the incidence of chronic pain and improve post‐operative shoulder function and arm mobility following mastectomy surgery? Timepoint(s) of evaluation of this end point: The time point is at 24 hours after the end of surgery. SECONDARY OUTCOME: Secondary end point(s): i) Number of PCA attempts in the first 24 hours following surgery as recorded by the PCA device. ii) VAS pain scores at 14 days and six months after surgery. iii) Brief Pain Inventory self‐completion questionnaire at six months. iv) Shoulder function (as measured by the Oxford Shoulder Score at 14 days and six months following surgery. The Oxford Shoulder Score is a validated questionnaire designed to determine the impact of shoulder function on activities of daily living. It is used in orthopaedic assessment of shoulder function as a marker for indication for shoulder surgery and provides a score from 0 to 48. v) Shoulder movement assessed by goniometry at 24 hours, 14 days and six months following surgery. vi)Duration of hospital stay in days as recorded in participants’ hospital notes. vii) Incidence of post‐operative nausea and/or vomiting (PONV). viii)Use of supplemental analgesics in the first 24 hours after surgery, as recorded on the inpatient drug chart. ix) Use of post‐operative anti‐emetics in the first 24 hours following surgery. x) Incremental cost effectiveness ratio. Timepoint(s) of evaluation of this end point: Time points are detailed above. They include the following times after completion of surgery: 24 hours 2 weeks 6 months INCLUSION CRITERIA: All women presenting for unilateral mastectomy surgery at the Royal Cornwall Hospitals NHS Trust and Royal Devon and Exeter NHS Foundation Trust: • Female • Aged 18 years and over • Scheduled for unilateral mastectomy with or without axillary involvement Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40