A prospective double-blinded randomised controlled trial to assess the efficacy of pre-emptive analgesia in forefoot surgery
| ISRCTN | ISRCTN47246491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47246491 |
| Secondary identifying numbers | N0227165434 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 27/09/2011
- 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 S Patil
Scientific
Scientific
Ward 34
The James Cook University Hospital
Marton Road
Cleveland
TS4 3BW
United Kingdom
| Phone | +44 |
|---|---|
| sunitpatil@doctors.org.uk |
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 | Does pre-operative administration of ankle block (pre-emptive analgesia) provide better post-operative pain control as compared to post-operative ankle block in patients undergoing bony forefoot surgery under a general anaesthetic? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Forefoot |
| Intervention | Patients meeting the inclusion criteria would be randomised to one of the two groups using a sealed envelope technique. One group of patients would receive an ankle block using 20ml of 0.25% bupivacaine after they are anaesthetised using a general anaesthetic, 10 minutes before the skin incision. The second group of patients would be administered an ankle block using the same method at the time of wound closure.The patient would be blinded to the type of ankle block. All the patients would be asked to score their post-operative pain at 4, 8 and 24 hours. The pain would be assessed using linear visual analogue scale. The person assessing the post-operative pain would also be blinded to the type of analgesia. Additional analgesia would be administered on patient's request. This would include 60mg of codeine and 1gm paracetamol. The patients would be asked to note the pain score whenever an analgesic is administered. The time of onset of pain and the frequency of analgesics required would be noted. Added 27 August 2008: trial stopped due to poor recruitment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Time of onset of post-operative pain 2. Pain scores at 4, 8 and 24 hours in both groups 3. Requirement of post-operative analgesia |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2005 |
| Completion date | 30/11/2005 |
| Reason abandoned (if study stopped) | Poor recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 40 patients in each group: 80 |
| Key inclusion criteria | 1. Patients undergoing bony forefoot surgery under a general anaesthetic 2. ASA grade 1-2 The sample size has been calculated by Dr Arts |
| Key exclusion criteria | 1. Patients with chronic pain problems 2. Patients with peripheral neuropathy 3. Patients needing regular analgesics for other painful conditions 4. Children of the age of 16 or below |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 30/11/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ward 34
Cleveland
TS4 3BW
United Kingdom
TS4 3BW
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
South Tees Hospitals NHS Trust (UK)
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 |
