COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement
Raktažodžiai
Santrauka
apibūdinimas
COPE (Cannabinoids to Obviate Pain Experiment after knee replacement) will be a single-centre, prospective, randomized, placebo-controlled, superiority trial, with two parallel groups designed to investigate the effect of cannabis as postoperative pain treatment compared to placebo on total opioid consumption after total knee replacement.
Eligible patients are: men and non-pregnant women aged ≥18 years scheduled to undergo primary total knee replacement. and with no opioid usage within the last 3 months or history of narcotic abuse.
Patients will be recruited at the department of orthopaedic surgery at St Michael's Hospital (Toronto - Canada), and informed consent will be obtained from those eligible. Central computer-generated randomization will be used to randomly assign participants to cannabis or placebo groups (1:1 ratio). Only the study pharmacist will know allocated treatments.
Datos
Paskutinį kartą patikrinta: | 08/31/2019 |
Pirmasis pateikimas: | 08/27/2018 |
Numatytas registravimas pateiktas: | 09/16/2018 |
Pirmas paskelbtas: | 09/17/2018 |
Paskutinis atnaujinimas pateiktas: | 09/26/2019 |
Paskutinis atnaujinimas paskelbtas: | 09/30/2019 |
Faktinė studijų pradžios data: | 04/30/2020 |
Numatoma pirminio užbaigimo data: | 05/14/2021 |
Numatoma studijų užbaigimo data: | 04/30/2022 |
Būklė ar liga
Intervencija / gydymas
Drug: Medical Cannabis
Drug: Placebo
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Experimental: Medical Cannabis Drug: Cannabidiol | Drug: Medical Cannabis Postoperative pain treatment |
Placebo Comparator: Placebo Placebo comparator | Drug: Placebo Placebo comparator |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 18 Years Į 18 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - 18 years of age and older - Men and women - Patients with radiographic confirmation and clinical correlation for severe osteoarthritis diagnosis with an indication for total knee replacement - Patients undergoing primary unilateral total knee replacement - Patient is able to provide informed consent to participation in the study Exclusion Criteria: - Pregnancy - Breastfeeding - Current opioid use - Cognitive impairment or mental illness (e.g., dementia, Alzheimer disease and psychoses), which will prevent patients from reliably providing primary outcome data - Unable to swallow an oral tablet (medication) - History of opiate, narcotic and alcohol abuse - Revision total knee replacement surgery - High risk of falls as determined by the treating physician - Patients refusing participation - Pre-existing/ regular cannabis use |
Rezultatas
Pirminės rezultatų priemonės
1. Opioid consumption [2 weeks after total knee replacement]
Antrinės rezultatų priemonės
1. Visual Analog Pain Scale [Pain scale will be assessed at 24 hours, 2, 6 and 12 weeks after knee replacement]
2. Oxford knee score [Questionnaire will be completed by patients at 6 weeks after knee replacement]
3. Health status and quality of life [Questionnaire will be completed by patients at 6 weeks after knee replacement]
4. Quality of recovery - 15 (QoR-15) [Questionnaire will be completed by patients at 12 weeks after knee replacement]
5. Self-reported opioid use and urinalysis [The test will be completed at 12 weeks after knee replacement]
6. Narcotic monitoring prescription [Will be assessed at 12 months after knee replacement]