Opioid-free Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Opioid-free Total Hip Arthroplasty: A Randomized Controlled Trial

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Other: Exclusion of opioid analgesics


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard multimodal analgesic pathway with opioids<br>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<br>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 | Other: Exclusion of opioid analgesics<br>* The intervention involves removing the option of patients having an opioid analgesic at any time point during the perioperative period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in post-operative pain assessed by the Visual analog scale (VAS) pain scores | Post-operative pain scores ranging from 0 to 10; 0 being no pain and 10 being the worst pain ever felt | From immediate post-operative period to 3 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain satisfaction as assessed by Hip Disability and Osteoarthritis Outcome Score (HOOS) | 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. | 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 | 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. | From pre-operative clinic visit to immediate post-operative period, and then to 3 months post-operatively |