Opioid-free Total Hip Arthroplasty

Hip Osteoarthritis Clinical Trial

Official title:

Opioid-free Total Hip Arthroplasty: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04421196
• Other study ID #: IRB00254474
• Status: Withdrawn
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

References & Publications (6)

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. Epub 2007 Nov 21. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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