A comparison of intrathecal diamorphine and intravenous morphine for postoperative analgesia in patients undergoing lumbar spinal surgery
| ISRCTN | ISRCTN01558905 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01558905 |
| Protocol serial number | N0015187634 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | North Cheshire Hospitals NHS Trust (UK) |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 28/08/2015
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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 Clare Hammell
Scientific
Scientific
North Cheshire Hospitals NHS Trust
Warrington Hospital
Lovely Lane
Warrington
WA5 1QG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A comparison of intrathecal diamorphine and intravenous morphine for postoperative analgesia in patients undergoing lumbar spinal surgery |
| Study objectives | Is intrathecal diamorphine injection an effective method for postoperative analgesia in patients following lumbar spinal surgery? Updated 28/08/2015: The trial was never started due to lack of suitable participants. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Analgesia |
| Intervention | Intrathecal diamorphine vs intravenous morphine |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Diamorphine, morphine |
| Primary outcome measure(s) |
The quality of postoperative analgesia. Patients pain scores will be measured in recovery and on days 1 and 2 postoperatively using a validated pain assessment tool (visual analogue scale 0-100mm). The assessor will be blinded to the patients treatment group. The amounts of morphine required to achieve adequate analgesia via a PCA system will be recorded in both groups. |
| Key secondary outcome measure(s) |
Secondary outcome measures include the presence of nausea, vomiting, sedation and pruritis. |
| Completion date | 01/04/2007 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | All ASA 1,2 and 3 patients between the ages of 18 to 70 years undergoing lumbar spinal surgery via a posterior surgical approach will be invited to participate in the study. |
| Key exclusion criteria | 1. Any contraindications to spinal injection (localised skin sepsis at proposed site of injection, coagulopathy) 2. History of allergy to any of the drugs used in the study 3. Severe hepatic or renal disease |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
North Cheshire Hospitals NHS Trust
Warrington
WA5 1QG
United Kingdom
WA5 1QG
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
