Comparision of epidural versus parental analgesia after colorectal surgery
| ISRCTN | ISRCTN48277388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48277388 |
| Secondary identifying numbers | N0084120704 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 01/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 Edward Smyth
Scientific
Scientific
Academic Surgical Unit
Castle Hill Hospital
Castle Rd
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom
| Phone | +44 (0)1482 875 875 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To evaluate the optimal method of pain control after such surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Colorectal |
| Intervention | Randomised controlled trial comparing 1. Morphine in a drip 2. Morphine in a drip plus ketamine infusion 3. Epidural analgesia in the spine Currently pain relief is provided by the patient having a button to press to deliver themselves some pain relieving drug. Every hour a nurse will check the patient and observe to make sure the patient is alright and happy with the pain relief. The nurse will ask a few questions on the quality of pain relief. The patient will be asked to do some deep breathing and to cough to aid this assessment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The patient will receive one of three pain control regimes: 1. Morphine in a drip 2. Morphine in a drip plus ketamine infusion 3. Epidural analgesia in their back (spine). The study is to compare the quality and quantity of pain relief, side effects and satisfaction with different drugs and methods of delivery. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 22/03/2002 |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 297 |
| Key inclusion criteria | 297 Samples are required. Normal post-operative analgesic requirements with some patients requiring ketamine. Input from pain management team. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 22/03/2002 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Surgical Unit
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom
HU16 5JQ
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
Research organisation
The North and South Bank Research and Development Consortium (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 |
