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Trial record 9 of 56 for:    Recruiting, Not yet recruiting, Available Studies | NOT (Use Disorders OR Marijuana Use OR Dependence OR Abuse OR Drug Use) | cannabinoids

Cannabinoids vs. Placebo on Persistent Post-surgical Pain Following TKA: A Pilot RCT

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ClinicalTrials.gov Identifier: NCT03825965
Recruitment Status : Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
St. Joseph's Healthcare Hamilton
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE January 30, 2019
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date March 8, 2019
Estimated Study Start Date  ICMJE April 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
Persistent post-surgical pain (PPSP) [ Time Frame: 6 months ]
Proportion of patients experiencing moderate to severe PPSP (average of pain over last week of ≥4 out of 10 on a numeric rating scale [NRS])
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03825965 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Opioid use [ Time Frame: 6 months ]
    Use of opioids (mean morphine equivalent dose [MED] change)
  • Peri-operative pain intensity [ Time Frame: 24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months ]
    Peri-operative pain measured on an 11-point NRS
  • Pain interference [ Time Frame: 24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months ]
    Pain interference measured by the Brief Pain Inventory (BPI-SF)
  • Physical function [ Time Frame: 6 months ]
    Physical component summary (PCS) score of the SF-12
  • Mental function [ Time Frame: 6 months ]
    Mental component summary (MCS) score of the SF-12
  • Return to function [ Time Frame: 6 months ]
    Return to 80% of pre-injury function (work, leisure, home activities)
  • Insomnia [ Time Frame: 6 months ]
    Insomnia symptoms on the Insomnia Severity Index (ISI)
  • Anxiety and depression [ Time Frame: 6 months ]
    Anxiety and depression on the Hospital Anxiety and Depression Scale (HADS)
  • Safety - Adverse events [ Time Frame: 6 months ]
    Serious and non-serious adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2019)
  • Feasibility - recruitment [ Time Frame: 6 months ]
    Ability to recruit 40 patients
  • Feasibility - retention [ Time Frame: 6 months ]
    Ability to follow 85% of patients
  • Feasibility - compliance [ Time Frame: 6 months ]
    Patient compliance with the study treatment (75% of patients comply with 75% of the study doses)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Cannabinoids vs. Placebo on Persistent Post-surgical Pain Following TKA: A Pilot RCT
Official Title  ICMJE The Effect of Cannabinoids vs. Placebo on Persistent Post-surgical Pain Following Total Knee Arthroplasty: A Multicenter, Randomized Pilot Trial
Brief Summary

Each year, approximately 67,000 Canadians undergo knee replacement surgery, and up to 20% develop persistent post-surgical pain. Persistent post-surgical pain is associated with depression, anxiety, unemployment, and reduced quality of life. Chronic pain after surgery is often managed with opioid therapy, which typically provides only modest benefits and is associated with rare but serious adverse events, such as overdose and death. A number of studies have found that greater pain just before and after knee replacement surgery is associated with the development of chronic pain, suggesting that reducing peri-operative pain may help prevent persistent post-surgical pain.

Medicinal cannabis has begun to emerge as a potential therapy for pain reduction, and produces effects largely due to 2 active components: (1) cannabidiol (CBD), and (2) tetrahydrocannabinol (THC). Studies of CBD have shown analgesic, anti-inflammatory, and anti-anxiety properties, but without the psychoactive effects (feeling 'high') that THC produces. This study will assess the feasibility of a definitive trial to explore whether adding CBD vs. placebo to usual care before and after surgery can reduce the rate of persistent post-surgical pain after total knee replacement. This study will randomize 40 patients to receive either CBD or placebo, and follow them for six months to confirm our ability to recruit patients, adhere to protocol, and capture full outcome data for at least 90% of patients.

Detailed Description Approximately 20% of patients develop persistent post-surgical pain (PPSP) after undergoing total knee arthroplasty (TKA), and higher pre-surgery and acute post-operative pain are associated with this outcome. Medicinal cannabis has anti-inflammatory and analgesic properties and may reduce peri-operative pain and the rate of PPSP following TKA. Cannabidiol (CBD) is the active ingredient of interest because of its anti-inflammatory effects and lack of psychoactive effects seen with tetrahydrocannabinol (THC). The primary objective of this pilot trial is to assess the feasibility of a definitive trial to determine the effect of medicinal cannabis, versus placebo, on the proportion of patients experiencing PPSP following TKA. The primary objective of the definitive trial is to determine if medicinal cannabis add-on therapy, versus placebo, reduces the proportion of patients experiencing PPSP at 6 months following TKA. The secondary objectives of the definitive trial are to determine if medicinal cannabis, versus placebo, reduces opioid use, reduces peri-operative pain interference, improves physical functioning, mental functioning, return to function, anxiety and depression, and sleep. The effect of medicinal cannabis, versus placebo, on the incidence of adverse events at 6 months post-surgery will also be examined. In this blinded multi-centre pilot trial, 40 patients will be randomized to receive either oral capsules of CBD oil or visually identical placebo in addition to standard of care pain medications. Participants will be followed for 6 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Drug: Cannabidiol (CBD)
    Oral cannabidiol capsules
  • Drug: Placebo oral capsule
    Visually identical placebo oral capsule (medium chain triglyceride oil)
Study Arms  ICMJE
  • Experimental: Cannabidiol (CBD)
    Oral medicinal cannabis (125 mg cannabidiol daily suspended in oil)
    Intervention: Drug: Cannabidiol (CBD)
  • Placebo Comparator: Placebo
    Visually identical placebo (medium chain triglyceride oil)
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing TKA aged 18 or older
  • Cognitive ability and English-language skills required to complete outcome measures
  • Provision of informed consent
  • Successful completion of the run-in period

Exclusion Criteria:

  • Severe cardio-respiratory disease (For operationalizing: ASA 4/NYHA 4)
  • Substance use disorder based on DSM-V criteria
  • Allergy or intolerance to cannabis, cannabis derivatives, or other ingredients of the study drug
  • Patients who are pregnant, planning to be pregnant, or breastfeeding
  • Revision TKA
  • Bilateral TKA
  • Presenting for their pre-surgical consultation less than 4 weeks before surgery
  • Patients with a chronic pain condition affecting the knee (other than osteoarthritis) (e.g.: patients with knee pain due to fibromyalgia or chronic pain syndrome will be excluded)
  • Unwilling or unable to follow the study protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anthony Adili, MD, P.Eng (905) 522-1155 ext 36062 adilia@mcmaster.ca
Contact: Kim Madden, PhD (289) 237-7380 maddenk@mcmaster.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03825965
Other Study ID Numbers  ICMJE Cannabis TKA Pilot Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE
  • St. Joseph's Healthcare Hamilton
  • Hamilton Health Sciences Corporation
Investigators  ICMJE
Principal Investigator: Anthony Adili, MD, P.Eng McMaster University
Principal Investigator: Jason W Busse, DC, PhD McMaster University
Principal Investigator: Vahid Ashoorion, MD, PhD McMaster University
PRS Account McMaster University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP