A randomised controlled study of Epidural Fentanyl Analgesia following Lumbar Laminectomy
| ISRCTN | ISRCTN89059431 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89059431 |
| Protocol serial number | Version 2 |
| Sponsor | Addenbrooke's Hospital (UK) |
| Funder | The costs of this trial are minimal. They will mostly be covered by internal department funds from the Department of Neurosurgery at Addenbrookes Hospital (UK). |
- Submission date
- 29/11/2006
- Registration date
- 28/02/2007
- Last edited
- 25/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Simon Thomson
Scientific
Scientific
Department of Neurosurgery
Box 166, Addenbrooke's Hospital
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)7963 343305 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled single blinded study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | EFALL |
| Study objectives | Epidural fentanyl is not more effective at controlling post-operative pain than current standard analgesic techniques. |
| Ethics approval(s) | Newcastle and North Tyneside Local Research Ethics Committee on 11/10/2006 (ref: 2 06/Q0906/126) |
| Health condition(s) or problem(s) studied | Degenerative lumbar canal stenosis |
| Intervention | Single bolus intraoperative epidural fentanyl (100 micrograms) versus best alternative medical care in patients following lumbar laminectomy. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fentanyl |
| Primary outcome measure(s) |
Post-operative pain score, day one and day two. |
| Key secondary outcome measure(s) |
1. Length of post-operative hospital stay |
| Completion date | 30/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Having a lumbar laminectomy for degenerative canal stenosis 2. 18 years or older 3. Able to give informed consent for this trial |
| Key exclusion criteria | 1. There is a Cerebrospinal Fluid (CSF) leak or the dura is opened 2. Contraindication to fentanyl as follows: a. respiratory depression b. obstructive airways disease c. concurrent administration with monoamine oxidase inhibitors, or within two weeks of their discontinuation d. known intolerance to fentanyl 3. Vulnerable group or unable to consent |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 30/11/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Neurosurgery
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
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? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | Yes | No |
