A randomised controlled study of Epidural Fentanyl Analgesia following Lumbar Laminectomy

ISRCTN ISRCTN89059431
DOI https://doi.org/10.1186/ISRCTN89059431
Secondary identifying numbers Version 2
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

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

Study designRandomised controlled single blinded study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymEFALL
Study objectivesEpidural 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) studiedDegenerative lumbar canal stenosis
InterventionSingle bolus intraoperative epidural fentanyl (100 micrograms) versus best alternative medical care in patients following lumbar laminectomy.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Fentanyl
Primary outcome measurePost-operative pain score, day one and day two.
Secondary outcome measures1. Length of post-operative hospital stay
2. Post-operative analgesia requirements
3. Side effects:
a. urinary retention
b. nausea
c. vomiting
d. pruritis
Overall study start date01/12/2006
Completion date30/11/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants100
Key inclusion criteria1. Having a lumbar laminectomy for degenerative canal stenosis
2. 18 years or older
3. Able to give informed consent for this trial
Key exclusion criteria1. 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 enrolment01/12/2006
Date of final enrolment30/11/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Neurosurgery
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Addenbrooke's Hospital (UK)
Hospital/treatment centre

c/o Dr John Bradley
Research and Development Department
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom

Phone +44 (0)1223 596377
Email sabine.klager@addenbrookes.nhs.uk
Website http://www.addenbrookes.org.uk/
ROR logo "ROR" https://ror.org/055vbxf86

Funders

Funder type

Hospital/treatment centre

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).

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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