Does a pain pump provide increased analgesia in forefoot reconstruction surgery?
| ISRCTN | ISRCTN78024440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78024440 |
| Secondary identifying numbers | N0051166093 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | Visual Analogue pain scores. Patient satisfaction levels. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2005 |
| 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 number of participants | 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
- England
- United Kingdom
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (PR)
Haywards Heath
RH16 4EX
United Kingdom
RH16 4EX
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Brighton and Sussex University Hospitals NHS Trust (UK) NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
