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 |
| Protocol serial number | N0301111200 |
| Sponsor | Department of Health (UK) |
| Funder | Blackpool Fylde & Wyre Hospitals NHS Trust (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | - |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Post operative pain |
| Intervention | Randomised controlled trial and telephone interviews for patient centered phase |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Pain relief response to therapy |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 86 |
| Total final enrolment | 100 |
| Key inclusion criteria | 86 patients undergoing major abdominal surgery nursed with epidural for postoperative pain relief, randomised to two groups |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 31/05/2002 |
| Date of final enrolment | 30/05/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Blackpool, Fylde and Wyre Hospitals NHS Trust
Blackpool
FY3 8NR
United Kingdom
FY3 8NR
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2005 | Yes | No | |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
