Does a pain pump provide increased analgesia in forefoot reconstruction surgery?
| ISRCTN | ISRCTN78024440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78024440 |
| Protocol serial number | N0051166093 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Brighton and Sussex University Hospitals NHS Trust (UK) NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 21/07/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
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
Mr Philip Stott
Scientific
Scientific
Brighton & Sussex University Hospitals NHS Trust (PR)
Princess Royal
Lewes Road
Haywards Heath
RH16 4EX
United Kingdom
| philstott@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Is a Patient Controlled Regional Anaesthesia (PCRA) technique better for patients undergoing forefoot reconstruction than the standard technique of nerve blocks and oral medication? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Forefoot reconstruction |
| Intervention | Patients will be randomised into either the pain pump group or the standard technique group. All will receive a standardised general anaesthetic. Post operatively, visual analogue pain scores and patient satisfaction will be recorded. The patients will be discharged with the pump in situ. Added 20/07/10: the trial never started. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Visual Analogue pain scores. Patient satisfaction levels. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2006 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | 30 patients undergoing forefoot reconstruction. |
| Key exclusion criteria | 1. Allergy to local anaesthetic 2. Any patient with previous surgery to that foot 3. Any patient requiring more extensive surgery e.g. Weil's osteonomies 4. Allergies/intolerances to NSAIDs |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 01/05/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (PR)
Haywards Heath
RH16 4EX
United Kingdom
RH16 4EX
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 |
