Ignite Creation Date:
2024-05-06 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03675971
Status:
UNKNOWN
Last Update Posted:
2019-10-01
First Post:
2018-08-28
Brief Title:
COPE Cannabinoids to Obviate Pain Experiment After Knee Replacement
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
COPE Cannabinoids to Obviate Pain Experiment After Knee Replacement
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
Brief Summary:
Total knee replacement is a major and painful orthopaedic joint and bone surgery where the knee joint is replaced with an artificial joint It is an effective and successful procedure to treat severe knee arthritis and reduce pain but many patients report intense pain after the surgery
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
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
Detailed Description:
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 Michaels 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 11 ratio Only the study pharmacist will know allocated treatments
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 Michaels 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 11 ratio Only the study pharmacist will know allocated treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None