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 design	Randomised controlled single blinded study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/12/2006
Completion date	30/11/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	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

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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