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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04585230
Other study ID # JLON20P.202
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 12, 2020
Est. completion date May 28, 2021

Study information

Verified date October 2020
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Total knee arthroplasty (TKA) is one the most common surgical treatments performed for end stage degenerative arthritis of the knee. More than 700,000 procedures are currently performed yearly in the United States. This procedure usually results in moderate-to-severe pain in the immediate post-operative period. Optimal pain control may allow early mobilization, accelerate rehabilitation, improve patient satisfaction, decrease length-of-stay, and optimize functional outcomes. The challenge, however, is to manage pain with alternative methods, reducing the role of opiate medications, which are highly addictive with myriad side effects. In this prospective randomized double-blinded controlled study, the investigators aim to evaluate the benefits of an over-the-counter (OTC) transdermal CBD preparation in patients undergoing primary total knee arthroplasty as a novel adjunct to the standard multi-modal analgesic regimen, to reduce postoperative pain and reduce the need for opiates after total knee arthroplasty.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 92
Est. completion date May 28, 2021
Est. primary completion date May 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Patients who have general anesthesia 2. Patients who have documented allergic reactions to ropivacaine in the local infiltration agents 3. Patients who have a contra-indication to the use of non-steroidal anti-inflammatory medications or are using therapeutic anticoagulation precluding them from using non-steroidal anti-inflammatory medications 4. Patients unable to complete a 100-ft walk baseline 5. Patients undergoing total knee arthroplasty as a conversion procedure following previous surgery 6. Patients undergoing TKA for posttraumatic arthritis 7. Patients undergoing TKA for steroid-induced or spontaneous avascular necrosis 8. Workers compensation patients 9. Patients refusing or not candidates for peripheral nerve blocks 10. Patients undergoing unicompartmental knee arthroplasty 11. Patients undergoing patellofemoral arthroplasty 12. Patients undergoing bilateral simultaneous or sequential primary total knee arthroplasty within the same hospital stay 13. Patients who have previously reported allergy to tetrahydrocannabinol or other cannabinoid compounds or develop allergic reactions to the formulation following use 14. Patients who are pregnant or choosing to be pregnant during the 6-week study period or are breast feeding during the study period 15. Patients who are on chronic narcotics pre-operatively 16. Patients who have end-stage cirrhosis, end-stage renal failures, or psychiatric conditions preventing adequate assessment of study outcome metrics 17. Patients with adequate cognitive function to participate and complete questionnaires for the study. 18. Patients unable or unwilling to follow-up and complete questionnaires for the study 19. Patients with active cancer and undergoing treatment precluding the assessment of outcome metrics 20. Patients with a history or diagnosis of chronic pain syndrome or Complex regional pain syndrome (CRPS) 21. Patients who are determined to be in severe pain from other concomitant conditions Exclusion Criteria: 1. patients <18 and >80 2. any patient who does not meet the inclusion criteria listed for this study

Study Design


Intervention

Drug:
CBD
CBD oil Roll-On Stick
Mineral Oil
Mineral Oil- Roll on Stick
Placebo
Roll- On stick with no CBD and no Mineral Oil

Locations

Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative change in pain and change the need for opiates after total knee arthroplasty. opioid consumption after surgery will be calculated in morphine equivalents 14 days
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