A clinical trial as proof of principle of the analgesic effectiveness of cannabinoids on postoperative pain

ISRCTN ISRCTN25994117
DOI https://doi.org/10.1186/ISRCTN25994117
Secondary identifying numbers G9901459
Submission date
23/10/2000
Registration date
23/10/2000
Last edited
07/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anita Holdcroft
Scientific

Magill Department of Anaesthesia
Faculty of Medicine
Imperial College of Science, Technology and Medicine
Chelsea and Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

+44 (0)20 8746 8026

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymCANPOP
Study objectivesTo determine if oral cannabinoids are analgesics and in the context of acute pain after surgery can provide pain relief. The primary outcome is the total pain relief score over 6 h based on hourly measurements from a verbal rating scale
Ethics approval(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedPostoperative pain
InterventionThere are four groups with a single dose of one of the following administered at random:
1. Standardised cannabis plant extract
2. Tetrahydrocannabinol
3. Ibuprofen
4. Placebo
Intervention typeProcedure/Surgery
Primary outcome measureThe primary outcome is the total pain relief score over 6 h based on hourly measurements from a verbal rating scale
Secondary outcome measuresNot provided at time of registration.
Overall study start date01/01/2001
Completion date12/04/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexNot Specified
Target number of participants400
Key inclusion criteriaElective surgery for primary knee arthroplasties or gynaecological surgery (hysterectomies, myomectomies and tubal surgery). Written informed consent, cooperative, reliable, age 18-60 years, weight greater than or equal to 50 kg (July 2006: changed from 60 kg), able to take oral medication, at least moderate pain, approximately 24-48 h after surgery
Key exclusion criteriaPreoperative pain medications. Analgesic drugs within 3 h of the study, surgical complications, haemorrhage (greater than 1000ml), ASA 3 or 4, any present or previous cardiovascular disease or medication, asthma, gastric ulcer, any present abnormal liver or renal function (as determined by laboratory tests), cannabis users within a month of the surgery, patients using sedatives, tranquillisers or anxiolytics, history of psychosis, pregnant (screening by pregnancy test) or lactating women, participation in a clinical study in the previous month and patients previously entered into this study.
Date of first enrolment01/01/2001
Date of final enrolment12/04/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Magill Department of Anaesthesia
London
SW10 9NH
United Kingdom

Sponsor information

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

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 01/05/2006 Yes No
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