Condition category
Musculoskeletal Diseases
Date applied
29/11/2006
Date assigned
28/02/2007
Last edited
25/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Simon Thomson

ORCID ID

Contact details

Department of Neurosurgery
Box 166
Addenbrooke's Hospital
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)7963 343305

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 measures

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

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

http://www.addenbrookes.org.uk/

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22926408

Publication citations

  1. 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.

Additional files

Editorial Notes