A randomised double-blind placebo-controlled trial of Sub-Pectoral catheter bupivacaine Infusion for post-mastectomy pai

Completed

Conditions: Post-mastectomy pain
Post-operative pain
Signs and Symptoms

Registration Number: ISRCTN71076101

Lead Sponsor: Royal Cornwall Hospital Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 70

Inclusion Criteria

Female patients over the age of 18 who are scheduled for elective single side mastectomy with axillary surgery at Royal Cornwall Hospital Trust will be recruited.

Exclusion Criteria

1. Concurrent enrolment in any other study/trial
2. Pregnancy
3. Bilateral surgery
4. Primary reconstructive surgery
5. Known allergy or sensitivity to local anaesthetic agents, morphine, paracetamol or ondansetron
6. Chronic opioid or non-opioid analgesic use
7. Inability to give informed consent
8. Inability to understand or use a patient-controlled analgesia (PCA) device
9. Inability to understand or complete the visual analogue assessment tools

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative analgesia as assessed by:<br>1. Total morphine requirements at 24 and 48 hours <br>2. Pain scores at rest on first wakening using a Verbal Rating Scale<br>3. Pain scores at rest and on movement using a Visual Analogue Scale at 24 and 48 hours<br>4. Time from end of surgery to first analgesia<br>5. Subsequent oral analgesia (oromorph) requirements

Secondary Outcome Measures

Name	Time	Method
1. Pain scores at rest and on movement using a Visual Analogue Scale at 10 days, 6 months and 1 year<br>2. Shoulder function assessment using Oxford Shoulder Score and Shoulder Goniometry at 24 hours, 48 hours, 10 days and 6 months<br>3. Incidence and severity of nausea and vomiting<br>4. Requirement for post-operative anti-emetic<br>5. Surgical complications, e.g., seroma/infection<br>6. Patient satisfaction at 10 days <br>7. Analgesia requirements at 6 months<br>8. Requirement for re-operation due to complication<br>9. Duration of post-operative hospital stay