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

ISRCTN	ISRCTN71076101
DOI	https://doi.org/10.1186/ISRCTN71076101
Protocol serial number	N/A
Sponsor	Royal Cornwall Hospital Trust (UK)
Funder	Royal Cornwall Hospital Trust (UK) - NHS clinical trial using existing resources

Submission date: 01/11/2007
Registration date: 03/04/2008
Last edited: 18/11/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gail Gillespie
Scientific

Royal Cornwall Hospital Trust
Treliske
Truro, Cornwall
TR1 3LJ
United Kingdom

Study information

Primary study design	Interventional
Study design	A prospective, single-centre, double blind randomised placebo-controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	SPI-Mas
Study objectives	The primary common complications of mastectomy with axillary node clearance are post-operative pain and slow recovery of shoulder function. Historically, mastectomy patients are managed on the wards with systemic opiates, either by intramuscular injection or using a Patient Controlled Analgesia (PCA) device. Problems commonly associated with this technique are inadequate pain control, post-operative nausea and vomiting, poor recovery of shoulder function and chronic pain. We ask the question: can post-operative analgesia be improved in this patient group by the use of local anaesthetic infusion via a sub pectoral catheter? This prospective, randomised double blind placebo-controlled study of patients undergoing mastectomy plus axillary sampling or clearance for breast cancer aims to investigate whether this technique confers any advantages over current practice.
Ethics approval(s)	Ethics approval will be submitted from the Cornwall NHS Hospitals Local Research and Ethics Committee. Pending as of 06/11/2007.
Health condition(s) or problem(s) studied	Post-mastectomy pain
Intervention	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 saline 0.9%). Thereafter continuous drug infusion will be 270 ml of either 0.25% bupivacaine or of 0.9% saline via an elastomeric infusion device delivering 5 ml/hr over 48 hours. All study arms have same duration. Initial phase of study is for the first 10 days following surgery, the second phase is the follow-up at 6 and 12 months. Total duration will therefore be 12 months.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Bupivacaine
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	70
Key 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.
Key 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
Date of first enrolment	01/01/2008
Date of final enrolment	01/06/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Cornwall Hospital Trust

Truro, Cornwall
TR1 3LJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes