Postoperative pain Surgery Postoperative pain
Conditions
Interventions
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
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the total pain relief score over 6 h based on hourly measurements from a verbal rating scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration. | — |
Countries
United Kingdom
Outcome results
None listed