Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SPI-Mas
Study hypothesis
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
Ethics approval will be submitted from the Cornwall NHS Hospitals Local Research and Ethics Committee. Pending as of 06/11/2007.
Study design
A prospective, single-centre, double blind randomised placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Bupivacaine
Primary outcome measures
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 outcome measures
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
Overall trial start date
01/01/2008
Overall trial end date
01/06/2009
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
70
Participant 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
Recruitment start date
01/01/2008
Recruitment end date
01/06/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Cornwall Hospital Trust
Truro, Cornwall
TR1 3LJ
United Kingdom
Sponsor information
Organisation
Royal Cornwall Hospital Trust (UK)
Sponsor details
c/o Cathryn Love-Rouse
Senior Manager Research and Development
Research and Development Directorate
Knowledge Spa
Truro
TR1 3HD
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Cornwall Hospital Trust (UK) - NHS clinical trial using existing resources
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary