An investigation to compare analgesia from 0.5 mg or 1 mg of intrathecal diamorphine when undergoing total knee replacement surgery
| ISRCTN | ISRCTN28694723 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28694723 |
| Secondary identifying numbers | N0247130747 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 06/11/2014
- 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
Dr Malcolm Watters
Scientific
Scientific
The Great Western Hospital
Marlborough Road
Swindon
SN3 6BB
United Kingdom
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 | Does a higher dose of diamorphine provide better pain relief with fewer side effects? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Total knee replacement (TKR) surgery analgesia |
| Intervention | Prior to total knee replacement surgery, patients will be randomised to: 1. 0.5 mg intrathecal diamorphine 2. 1 mg intrathecal diamorphine |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 10/03/2003 |
| Completion date | 31/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Adult primary total knee replacements 2. Aged 18 - 70 years |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 10/03/2003 |
| Date of final enrolment | 31/03/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Great Western Hospital
Swindon
SN3 6BB
United Kingdom
SN3 6BB
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Swindon and Marlborough 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 |
