Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 2
Study information
Scientific title
Acronym
EFALL
Study hypothesis
Epidural fentanyl is not more effective at controlling post-operative pain than current standard analgesic techniques.
Ethics approval
Newcastle and North Tyneside Local Research Ethics Committee on 11/10/2006 (ref: 2 06/Q0906/126)
Study design
Randomised controlled single blinded study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Fentanyl
Primary outcome measure
Post-operative pain score, day one and day two.
Secondary outcome measures
1. Length of post-operative hospital stay
2. Post-operative analgesia requirements
3. Side effects:
a. urinary retention
b. nausea
c. vomiting
d. pruritis
Overall trial start date
01/12/2006
Overall trial end date
30/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
100
Participant 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
Recruitment start date
01/12/2006
Recruitment end date
30/11/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Neurosurgery
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Addenbrooke's Hospital (UK)
Sponsor details
c/o Dr John Bradley
Research and Development Department
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 596377
sabine.klager@addenbrookes.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
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).
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22926408
Publication citations
-
Results
Guilfoyle MR, Mannion RJ, Mitchell P, Thomson S, Epidural fentanyl for postoperative analgesia after lumbar canal decompression: a randomized controlled trial., Spine J, 2012, 12, 8, 646-651, doi: 10.1016/j.spinee.2012.07.007.