Opioid-free Total Hip Arthroplasty: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Osteoarthritis
- Sponsor
- Johns Hopkins University
- Primary Endpoint
- Change in post-operative pain assessed by the Visual analog scale (VAS) pain scores
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
The primary objective of investigators' proposed study is to demonstrate that the following two cohorts undergoing total hip arthroplasty will have equivalent visual analog scale (VAS) scores up to 3 months post-operatively: one that is administered a modified multimodal analgesic pathway without opioids and the other administered the current standard multimodal analgesic pathway used at Johns Hopkins Bayview Hospital (which includes opioids). The secondary objective is to demonstrate that these cohorts will also have equivalent functional outcomes as determined by both objective measures (such as hip range of motion) and patient-reported outcome measures, such as the Hip Disability and Osteoarthritis Outcome Score (HOOS) and the University of California at Los Angeles (UCLA) activity score.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients of all ages with end-stage primary hip osteoarthritis.
Exclusion Criteria
- •Patients with creatinine clearance between 30 and 60 mL/min
- •Use of any opioid analgesics in the 6 months preceding surgery
- •Revision total hip arthroplasty
- •Patients with liver insufficiency
- •Patients on chronic anticoagulation
- •Workers compensation patients
- •Patients who cannot receive Acetaminophen, Ketorolac, Celecoxib, or Gabapentin for any reason (e.g. allergies)
Outcomes
Primary Outcomes
Change in post-operative pain assessed by the Visual analog scale (VAS) pain scores
Time Frame: From immediate post-operative period to 3 months post-operatively
Post-operative pain scores ranging from 0 to 10; 0 being no pain and 10 being the worst pain ever felt
Secondary Outcomes
- Change in pain satisfaction as assessed by Hip Disability and Osteoarthritis Outcome Score (HOOS)(From pre-operative clinic visit to immediate post-operative period, then to 3 months post-operatively)
- Change in Physical Activity level as assessed by the University of California at Los Angeles (UCLA) Scale(From pre-operative clinic visit to immediate post-operative period, and then to 3 months post-operatively)