Does continuous rectal sheath block decrease postoperative opioid requirement?
| ISRCTN | ISRCTN46452718 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46452718 |
| Protocol serial number | N0283122688 |
| Sponsor | Department of Health (UK) |
| Funder | Commercial educational grant |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/01/2014
- 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 William Woods
Scientific
Scientific
Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing, West Sussex
BN11 2DH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Does the intermittent infiltration of 0.25% bupivacaine delivered by an epidural catheter into the rectus sheath decrease the opioid requirement postoperatively after a midline laparotomy? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain, nausea, vomiting, itching |
| Intervention | 1. 0.25% Bupivacaine 2. Saline |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | bupivacaine |
| Primary outcome measure(s) |
The primary outcome measure will be the total amount of opiate used in the intravenous patient controlled analgesia (IVPCA) in the first 48 h. |
| Key secondary outcome measure(s) |
Secondary outcome measures will be forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) at 24 and 48 h, the number of episodes of nausea, vomiting, itching, the sedation score, and respiratory rate, the time to passage of flatus and the length of hospital stay. |
| Completion date | 20/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | 40 consenting patients due to undergo a laparotomy. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 20/04/2002 |
| Date of final enrolment | 20/06/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing, West Sussex
BN11 2DH
United Kingdom
BN11 2DH
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 |
