COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement
NCT ID: NCT03675971
Last Updated: 2019-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
220 participants
INTERVENTIONAL
2020-05-01
2022-05-31
Brief Summary
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Postoperative pain control is predominated by opioids (morphine-based drugs). While opioids are effective to manage the pain, they can have acute and chronic complications, including confusion, nausea, vomiting, constipation and high risk of addiction.
Medical cannabis is an effective and safe alternative for pain treatment. Recent studies showed that patients have reported a reduction in opioid usage when taking cannabis as a substitute for pain relief.
This study aims to investigate whether adding medical cannabis (cannabidiol - CBD) treatment will decrease the amount of opiates needed in the first 2 weeks after knee replacement compared to a group given placebo.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Medical Cannabis
Drug: Cannabidiol
Cannabinol
Postoperative pain treatment
Placebo
Placebo comparator
Placebo oral capsule
Placebo comparator
Interventions
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Cannabinol
Postoperative pain treatment
Placebo oral capsule
Placebo comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Amit Atrey, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Luana Melo, PhD
Role: primary
References
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Canadian Institute for Health Information. Hip and Knee Replacements in Canada, 2016-2017: Canadian Joint Replacement Registry Annual Report. Ottawa, ON: CIHI; 2018
Terkawi AS, Mavridis D, Sessler DI, Nunemaker MS, Doais KS, Terkawi RS, Terkawi YS, Petropoulou M, Nemergut EC. Pain Management Modalities after Total Knee Arthroplasty: A Network Meta-analysis of 170 Randomized Controlled Trials. Anesthesiology. 2017 May;126(5):923-937. doi: 10.1097/ALN.0000000000001607.
Canata GL, Casale V, Chiey A. Pain management in total knee arthroplasty: efficacy of a multimodal opiate-free protocol. Joints. 2017 Feb 7;4(4):222-227. doi: 10.11138/jts/2016.4.4.222. eCollection 2016 Oct-Dec.
Mohamadi A, Chan JJ, Lian J, Wright CL, Marin AM, Rodriguez EK, von Keudell A, Nazarian A. Risk Factors and Pooled Rate of Prolonged Opioid Use Following Trauma or Surgery: A Systematic Review and Meta-(Regression) Analysis. J Bone Joint Surg Am. 2018 Aug 1;100(15):1332-1340. doi: 10.2106/JBJS.17.01239.
Hadlandsmyth K, Vander Weg MW, McCoy KD, Mosher HJ, Vaughan-Sarrazin MS, Lund BC. Risk for Prolonged Opioid Use Following Total Knee Arthroplasty in Veterans. J Arthroplasty. 2018 Jan;33(1):119-123. doi: 10.1016/j.arth.2017.08.022. Epub 2017 Aug 24.
Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.
Goesling J, Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, Clauw DJ, Brummett CM. Trends and predictors of opioid use after total knee and total hip arthroplasty. Pain. 2016 Jun;157(6):1259-1265. doi: 10.1097/j.pain.0000000000000516.
Franklin PD, Karbassi JA, Li W, Yang W, Ayers DC. Reduction in narcotic use after primary total knee arthroplasty and association with patient pain relief and satisfaction. J Arthroplasty. 2010 Sep;25(6 Suppl):12-6. doi: 10.1016/j.arth.2010.05.003. Epub 2010 Jun 26.
Soffin EM, Waldman SA, Stack RJ, Liguori GA. An Evidence-Based Approach to the Prescription Opioid Epidemic in Orthopedic Surgery. Anesth Analg. 2017 Nov;125(5):1704-1713. doi: 10.1213/ANE.0000000000002433.
Cozowicz C, Olson A, Poeran J, Morwald EE, Zubizarreta N, Girardi FP, Hughes AP, Mazumdar M, Memtsoudis SG. Opioid prescription levels and postoperative outcomes in orthopedic surgery. Pain. 2017 Dec;158(12):2422-2430. doi: 10.1097/j.pain.0000000000001047.
Lynch ME, Campbell F. Cannabinoids for treatment of chronic non-cancer pain; a systematic review of randomized trials. Br J Clin Pharmacol. 2011 Nov;72(5):735-44. doi: 10.1111/j.1365-2125.2011.03970.x.
Schrot RJ, Hubbard JR. Cannabinoids: Medical implications. Ann Med. 2016;48(3):128-41. doi: 10.3109/07853890.2016.1145794. Epub 2016 Feb 25.
Manzanares J, Julian M, Carrascosa A. Role of the cannabinoid system in pain control and therapeutic implications for the management of acute and chronic pain episodes. Curr Neuropharmacol. 2006 Jul;4(3):239-57. doi: 10.2174/157015906778019527.
Vigil JM, Stith SS, Adams IM, Reeve AP. Associations between medical cannabis and prescription opioid use in chronic pain patients: A preliminary cohort study. PLoS One. 2017 Nov 16;12(11):e0187795. doi: 10.1371/journal.pone.0187795. eCollection 2017.
Lucas P, Walsh Z. Medical cannabis access, use, and substitution for prescription opioids and other substances: A survey of authorized medical cannabis patients. Int J Drug Policy. 2017 Apr;42:30-35. doi: 10.1016/j.drugpo.2017.01.011. Epub 2017 Feb 9.
Other Identifiers
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RCT19-366965
Identifier Type: -
Identifier Source: org_study_id
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