Post-operative pain (in major orthopaedic, gynaecologic, abdominal and plastic procedures) Signs and Symptoms Post-operative pain
Conditions
Interventions
Group A: 1 mg nabilone, one capsule of 1 mg + one capsule of placebo, 8 hourly
Group B: 2 mg nabilone, two capsules of 1 mg, 8 hourly
Group C: 50 mg ketoprofen, one capsule of 50 mg + one capsule of p
Sponsors
Hôtel-Dieu de Montréal (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 18 - 75 years old, either sex, scheduled for major orthopaedic surgery 2. Patients using a morphine patient controlled analgesia (PCA) device post-operatively 3. Patients should be American society of Anaesthesiology (ASA) pre-operative status I, II or III 4. Patients willing and able to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients using cannabis or other substance of abuse, alcoholism 2. Patients where morphine is not the drug of choice for PCA 3. Patients with planned concomitant medication during the study with any of the following: non-steroidal anti-inflammatory drugs, acetaminophen, more than 300 mg acetyl salicylic acid per day, sedatives, anticonvulsants, antidepressants 4. Patients with ischaemic heart disease, cardiac arrhythmias failure 5. Patients with history of gastric or duodenal ulcer, renal insufficiency or asthma 6. Patients with chronic pain conditions and/or patients receiving chronic opioid therapy 7. Patients with history of psychiatric illness 8. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A total (24 hours) morphine Patient Controlled Analgesia (PCA) consumption hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain intensity as measured by the Visual Analogue Scale (VAS) 2. Anti-emetic properties of nabilone 3. Assessment of mood and anxiety prior to surgery 4. Time to discharge criteria as indices of post-operative recovery 5. Quality of sleep 6. Incidence of side effects such as sedation, euphoria ('high'), psychotic episodes | — |
Countries
Canada
Outcome results
None listed