Opioid-free Total Hip Arthroplasty

NCT04421196 | Withdrawn DMC

• 1 other identifier: IRB00254474
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Standard multimodal analgesic pathway with opioids

NO INTERVENTION

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

Modified multimodal analgesic pathway without opioids

EXPERIMENTAL

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

Interventions

Exclusion of opioid analgesics OTHER

The intervention involves removing the option of patients having an opioid analgesic at any time point during the perioperative period.

Modified multimodal analgesic pathway without opioids

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of all ages with end-stage primary hip osteoarthritis.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (6)

• 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.

  PMID: 29570781 BACKGROUND

• 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.

  PMID: 31327956 BACKGROUND

• 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.

  PMID: 31072655 BACKGROUND

• 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.

  PMID: 28059869 BACKGROUND

• 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.

  PMID: 10861154 BACKGROUND

• 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.

  PMID: 18028577 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Julius Oni, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 9, 2020
• Study Start: September 15, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share