A prospective randomised double-blinded comparison of 0.125% and 0.0625% bupivicaine for the management of postoperative pain in patients undergoing major abdominal surgery.
| ISRCTN | ISRCTN45045119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45045119 |
| Secondary identifying numbers | N0301111200 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 20/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Fiona Duncan
Scientific
Scientific
Blackpool, Fylde and Wyre Hospitals NHS Trust
Blackpool
FY3 8NR
United Kingdom
| Phone | +44 (0)1253 300000 |
|---|---|
| abc@123.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | - |
| Study hypothesis | A comparison of two epidural infusion doses for post-operative pain relief and to explore the experience of patients who have undergone epidural pain management. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Signs and Symptoms: Post operative pain |
| Intervention | Randomised controlled trial and telephone interviews for patient centered phase |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain relief response to therapy |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 31/05/2002 |
| Overall study end date | 30/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 86 |
| Total final enrolment | 100 |
| Participant inclusion criteria | 86 patients undergoing major abdominal surgery nursed with epidural for postoperative pain relief, randomised to two groups |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 31/05/2002 |
| Recruitment end date | 30/05/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Blackpool, Fylde and Wyre Hospitals NHS Trust
Blackpool
FY3 8NR
United Kingdom
FY3 8NR
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Blackpool Fylde & Wyre 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Duncan F., Haigh C., Cupitt J., Vernon P., Marshall J., Nield A. . "A prospective randomized pragmatic double-blinded 0.125% and 0.0625% bupivicaine for the management of pain after operation in patients undergoing major abdominal surgery" Acute Pain, vol.7, No.2, pp.85-93 issn: 1366-0071 | 01/08/2005 | Yes | No | |
| Results article | results | 01/08/2005 | Yes | No |
Editorial Notes
20/02/2020: The following changes have been made:
1. The publication status has been updated.
2. The total final enrolment number has been added from the 2005 reference.
