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| A randomised double-blind placebo-controlled trial of Sub-Pectoral catheter bupivacaine Infusion for post-mastectomy pain |
| Source of record | UK Trials |
| ISRCTN | ISRCTN71076101 |
| Date ISRCTN assigned | 03/04/2008 |
| Local reference number(s) | N/A |
| Public title | A randomised double-blind placebo-controlled trial of Sub-Pectoral catheter bupivacaine Infusion for post-mastectomy pain |
| Scientific title | |
| Acronym | SPI-Mas |
| Disease/condition/study domain | Post-mastectomy pain |
| 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. |
| Design/methodology | A prospective, single-centre, double blind randomised placebo-controlled study |
| Research ethics review | Ethics approval will be submitted from the Cornwall NHS Hospitals Local Research and Ethics Committee. Pending as of 06/11/2007. |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - 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 |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 01/06/2009 |
| Status of trial | Ongoing |
| Target number of participants | 70 |
| 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 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. |
| 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 |
| 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 |
| Sources of funding | Royal Cornwall Hospital Trust (UK) - NHS clinical trial using existing resources |
| Sponsor name | Royal Cornwall Hospital Trust (UK) |
| Sponsor details | c/o Cathryn Love-Rouse Senior Manager Research and Development Research and Development Directorate Knowledge Spa Truro United Kingdom TR1 3HD |
| Sponsor website | http://www.cornwall.nhs.uk/RCHT/Home.aspx |
| Contact name | Dr Gail Gillespie |
| Contact details | Royal Cornwall Hospital Trust Treliske Truro, Cornwall United Kingdom TR1 3LJ |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN71076101 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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