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BMC Musculoskeletal Disorders

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Open Access 01-12-2021 | Opioids | Study protocol

Study protocol: randomized controlled trial of opioid-free vs. traditional perioperative analgesia in elective orthopedic surgery

Authors: Elaine Z. Shing, Daniel Leas, Caleb Michalek, Meghan K. Wally, Nady Hamid

Published in: BMC Musculoskeletal Disorders | Issue 1/2021

Abstract

Background

The medical community is beginning to recognize the contribution of prescription opioids in the growing national opioid crisis. Many studies have compared the safety and efficacy of alternative analgesics to opioids, but none utilizing a completely opioid-free perioperative protocol in orthopedics.

Methods

We developed and tested an opioid-free perioperative analgesic pathway (from preoperative to postoperative period) among patients undergoing common elective orthopedic procedures. Patients will be randomized to receive either traditional opioid-including or completely opioid-free perioperative medications. This study is being conducted across multiple orthopedic subspecialties in patients undergoing the following common elective orthopedic procedures: single-level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty (THA), and total shoulder arthroplasty/reverse total shoulder arthroplasty (TSA/RTSA). The primary outcome measure is pain score at 24 h postoperatively. Secondary outcome measures include pain scores at additional time points, medication side effects, and several patient-reported variables such as patient satisfaction, quality of life, and functional status.

Discussion

We describe the methods for a feasibility randomized controlled trial comparing opioid-free perioperative analgesics to traditional opioid-including protocols. We present this study so that it may be replicated and incorporated into future studies at other institutions, as well as disseminated to additional orthopedic and/or non-orthopedic surgical procedures. The ultimate goal of presenting this protocol is to aid recent efforts in reducing the impact of prescription opioids on the national opioid crisis.

Trial registration

The protocol was approved by the local institutional review board and registered with clinicaltrials.gov (Identifier: NCT04176783) on November 25, 2019, retrospectively registered

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Title: Study protocol: randomized controlled trial of opioid-free vs. traditional perioperative analgesia in elective orthopedic surgery
Authors: Elaine Z. Shing
Daniel Leas
Caleb Michalek
Meghan K. Wally
Nady Hamid
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Opioids
Opioids
Analgesics in Dentistry
Hip-TEP
Hip-TEP
Published in: BMC Musculoskeletal Disorders / Issue 1/2021
Electronic ISSN: 1471-2474
DOI: https://doi.org/10.1186/s12891-021-03972-9

At a glance: The STEP trials

Springer Medicine

Study protocol: randomized controlled trial of opioid-free vs. traditional perioperative analgesia in elective orthopedic surgery

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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