Opioid-free Total Hip Arthroplasty

Opioid-free Total Hip Arthroplasty: A Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Other: Exclusion of opioid analgesics

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Julius Oni, M.D., Johns Hopkins University

Publications and helpful links

General Publications

• Madras BK. The President's Commission on Combating Drug Addiction and the Opioid Crisis: Origins and Recommendations. Clin Pharmacol Ther. 2018 Jun;103(6):943-945. doi: 10.1002/cpt.1050. Epub 2018 Mar 23.
• Rodriguez-Merchan EC, Vaquero-Picado A, Ruiz-Perez JS. Correction to: Opioid-Free Total Knee Arthroplasty? Local Infiltration Analgesia Plus Multimodal Blood-Loss Prevention Make it Possible. HSS J. 2019 Jul;15(2):209. doi: 10.1007/s11420-019-09679-x. Epub 2019 Apr 1.
• Leas DP, Connor PM, Schiffern SC, D'Alessandro DF, Roberts KM, Hamid N. Opioid-free shoulder arthroplasty: a prospective study of a novel clinical care pathway. J Shoulder Elbow Surg. 2019 Sep;28(9):1716-1722. doi: 10.1016/j.jse.2019.01.013. Epub 2019 May 6.
• Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
• Stevens RD, Van Gessel E, Flory N, Fournier R, Gamulin Z. Lumbar plexus block reduces pain and blood loss associated with total hip arthroplasty. Anesthesiology. 2000 Jul;93(1):115-21. doi: 10.1097/00000542-200007000-00021.
• Becchi C, Al Malyan M, Coppini R, Campolo M, Magherini M, Boncinelli S. Opioid-free analgesia by continuous psoas compartment block after total hip arthroplasty. A randomized study. Eur J Anaesthesiol. 2008 May;25(5):418-23. doi: 10.1017/S026502150700302X. Epub 2007 Nov 21.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 15, 2022
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Narcotics; Analgesics, Opioid; Analgesics
• Other Study ID Numbers: IRB00254474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No