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.
Full Title of Study: “Opioid-free Total Hip Arthroplasty: A Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: December 1, 2021
- Other: Exclusion of opioid analgesics
- The intervention involves removing the option of patients having an opioid analgesic at any time point during the perioperative period.
Arms, Groups and Cohorts
- No Intervention: Standard multimodal analgesic pathway with opioids
- This is the control group, who will receive the current standard multimodal analgesic regimen, which includes opioids following total hip arthroplasty at Johns Hopkins Bayview Hospital. The current standard multimodal analgesic regimen utilizes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Opioid (fentanyl) & Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: 0.25 % bupivacaine with epinephrine and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Oxycodone 5-10 mg PO, IV opioids (Morphine, hydromorphone), Acetaminophen 1000 mg PO q6hr
- Experimental: Modified multimodal analgesic pathway without opioids
- This is the experimental group, who will receive a modified multimodal analgesic regimen, which excludes the use of any opioids. The modified multimodal analgesic regimen utilizes the following medications: includes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: Liposomal bupivacaine, 0.25 % bupivacaine with epinephrine, Betamethasone sodium phosphate, betamethasone acetate and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Ketamine IV, Ketorolac 15 mg PO, Acetaminophen 1000 mg PO q6hr
Clinical Trial Outcome Measures
- 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
- Change in pain satisfaction as assessed by Hip Disability and Osteoarthritis Outcome Score (HOOS)
- Time Frame: From pre-operative clinic visit to immediate post-operative period, then to 3 months post-operatively
- A patient-reported measure that assesses components such as assesses patient pain, satisfaction including stiffness and range of motion, activity limitations-daily living, sports and recreation function, and quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms.
- Change in Physical Activity level as assessed by the University of California at Los Angeles (UCLA) Scale
- Time Frame: From pre-operative clinic visit to immediate post-operative period, and then to 3 months post-operatively
- The UCLA scale is a patient-reported measure ranging from 1 to 10. Patients indicate their most appropriate activity level, with 1 defined as “no physical activity, dependent on others” and 10 defined as “regular participation in impact sports.”
Participating in This Clinical Trial
- Patients of all ages with end-stage primary hip osteoarthritis.
- 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)
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Johns Hopkins University
- Provider of Information About this Clinical Study
- Overall Official(s)
- Julius Oni, M.D., Principal Investigator, Johns Hopkins University
- Overall Contact(s)
- Kawsu Barry, M.D., 3202238080, firstname.lastname@example.org
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