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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71076101

Enrollment

Registered

2008-04-03

Start date

2008-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-mastectomy pain Signs and Symptoms Post-operative pain

Interventions

Local anaesthetic bupivacaine infusion (initial bolus of 20 ml of 0.5% sterile bupivacaine) via a sub-pectoral catheter inserted intra-operatively versus saline control (initial bolus of 20 ml sterile

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026