Condition category
Surgery
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
07/09/2009
Prospective/Retrospective
Prospectively 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

Dr Anita Holdcroft

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9901459

Study information

Scientific title

Acronym

CANPOP

Study hypothesis

To 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

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Postoperative pain

Intervention

There 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 type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome is the total pain relief score over 6 h based on hourly measurements from a verbal rating scale

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/01/2001

Overall trial end date

12/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Elective 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

400

Participant exclusion criteria

Preoperative 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.

Recruitment start date

01/01/2001

Recruitment end date

12/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Magill Department of Anaesthesia
London
SW10 9NH
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16645457

Publication citations

  1. Results

    Holdcroft A, Maze M, Doré C, Tebbs S, Thompson S, A multicenter dose-escalation study of the analgesic and adverse effects of an oral cannabis extract (Cannador) for postoperative pain management., Anesthesiology, 2006, 104, 5, 1040-1046.

Additional files

Editorial Notes