Clinical trial NCT04421196: Opioid-free Total Hip Arthroplasty
Official title: Opioid-free Total Hip Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in post-operative pain assessed by the Visual analog scale (VAS) pain scores
timeFrame: From immediate post-operative period to 3 months post-operatively
Secondary outcomes:
measure: Change in pain satisfaction as assessed by Hip Disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: From pre-operative clinic visit to immediate post-operative period, then to 3 months post-operatively
measure: Change in Physical Activity level as assessed by the University of California at Los Angeles (UCLA) Scale
timeFrame: From pre-operative clinic visit to immediate post-operative period, and then to 3 months post-operatively
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Julius Oni, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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. doi: 10.1097/00000542-200007000-00021.
citation: 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.