To compare analgesia and side effects of intrathecal fentanyl and intrathecal morphine
| ISRCTN | ISRCTN49793641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49793641 |
| Protocol serial number | N/A |
| Sponsor | North Wales NHS Trust (UK) |
| Funder | North Wales NHS Trust (UK) |
- Submission date
- 02/03/2009
- Registration date
- 27/03/2009
- Last edited
- 16/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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 Vivienne Ng
Scientific
Scientific
North wales NHS Trust
Bodelwyddan
Denbighshire
LL18 5UJ
United Kingdom
| Phone | +44 1745 583910 |
|---|---|
| hyvng@doctors.org.uk |
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 randomised controlled trial to compare analgesia and side effects of intrathecal fentanyl and intrathecal morphine |
| Study objectives | Null hypothesis: There is no difference in analgesic requirements in patients using 25 mcg fentanyl, 50 mcg morphine or 100 mcg of morphine intrathecally alongside 2.5 ml 0.5% heavy marcaine within the first 24 hours post operation. |
| Ethics approval(s) | To be submitted to the North Wales (Central) Research Ethics Committee in March 2009 (ref: 09/WNo02/6). |
| Health condition(s) or problem(s) studied | Analgesia and anaesthesia in orthopaedic surgery |
| Intervention | The 90 patients will be randomised into 3 groups. The first group will be given 2.5 ml of heavy bupivacaine 0.5% with 25 mcg of fentanyl intrathecally, the second group will be given 2.5 ml of heavy bupivacaine 0.5% with 50 mcg of morphine intrathecally and the last group will be given 2.5 ml of heavy bupivacaine 0.5% with 100 mcg of morphine intrathecally. To minimise operator factors, there will be one anaesthetist performing the anaesthesia. Intraoperatively, patients will be given 1 g paracetamol (intravenous). The usage of vasopressors and fluids intraoperatively will be noted. Patients are observed postoperatively in high care and the usage of patient controlled analgesia (PCA) morphine as well as respiratory rates and other side effects will be monitored closely. Patients are only given paracetamol (intravenous) 1 g four times a day (qds) in the first 24 hours as well as the morphine PCA. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fentanyl, morphine |
| Primary outcome measure(s) |
Analgesic usage in first 24 hours. |
| Key secondary outcome measure(s) |
The following will be monitored for the first 24 hours: |
| Completion date | 30/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | 1. Both males and females, aged 18-100 2. American Society of Anesthesiologists (ASA) 1 and 2 3. Patients planned for an elective orthopaedic surgery needing spinal anaesthetic as part of routine anaesthetic management |
| Key exclusion criteria | 1. Children <18 years old 2. Pregnant women 3. Patients with contraindications to spinal anaesthetic 4. Patients unable to give informed consent |
| Date of first enrolment | 01/05/2009 |
| Date of final enrolment | 30/04/2010 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
North wales NHS Trust
Denbighshire
LL18 5UJ
United Kingdom
LL18 5UJ
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 |
Editorial Notes
16/06/2016: No publications found, verifying study status with principal investigator.
