Periportal Bupivacaine For Pain Relief After Laparoscopic Cholecysectomy
| ISRCTN | ISRCTN29748753 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29748753 |
| Secondary identifying numbers | N0650147577 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 08/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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 R Anderson
Scientific
Scientific
Surgical CSG
Ormskirk Dist Gen Hosp
Wigan Road
Ormskirk
L39 2AZ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 1. Does Pre-incisional injection of bupivacaine decrease postoperative pain following laparoscopic cholecystectomy and allow for early discharge from hospital? 2. To determine any early or late (6 week) related complications. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Post operative pain |
| Intervention | Randomisation of patients to intervention group and control group. |
| Intervention type | Other |
| Primary outcome measure | 1. Pain intensity scored using visual analogue scale at 4, 6 and 24 hrs from the commencement of operation 2. Time to first demand of analgesia 3. Total analgesic requirement in first 24 hrs 4. Assessment of opportunity for same day discharge 5. Assessment of early/late (6 weeks) postoperative complications 6. Scar quality at 6 weeks |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 17/01/2002 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 60 |
| Key inclusion criteria | 60 patients from waiting lists of two General Surgeons based at Ormskirk District General Hospital (RJL Anderson; NK Matar) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 17/01/2002 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Surgical CSG
Ormskirk
L39 2AZ
United Kingdom
L39 2AZ
United Kingdom
Sponsor information
Department of Health
Government
Government
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
Southport and Ormskirk Hospital 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 |
