Evidence map›Paper›PMID 33485328›Full record

ArticleBMC musculoskeletal disorders2021

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

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

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC musculoskeletal disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04176783 (Carolina's Opioid Reduction Effort), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04176783 nacompletednot on this map

Carolina's Opioid Reduction Effort

TypeinterventionalSponsorOrthoCarolina Research Institute, Inc.Ran2018 to 2024Enrolled511ConditionsPain ManagementArmsOpioids, Opioid-Free
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 10 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 1 country.

Elaine Z ShingCarolinas Medical Center, Atrium Health Musculoskeletal Institute, P.O. Box 32861, Charlotte, NC, 28232, USA. elaine.shing@atriumhealth.org.ORCID http://orcid.org/0000-0002-1469-0925
Daniel LeasCarolina Neurosurgery and Spine Associates, Charlotte, NC, USA.
Caleb MichalekOrthoCarolina Research Institute, Charlotte, NC, USA.
Meghan K WallyCarolinas Medical Center, Atrium Health Musculoskeletal Institute, P.O. Box 32861, Charlotte, NC, 28232, USA.
Nady HamidOrthoCarolina Shoulder and Elbow Center, Charlotte, NC, USA.
Carolinas Medical Center · USCarolina Neurosurgery and Spine Associates · USOrthoCarolina · USOrthoCarolina Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

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

Indexed as

AnalgesiaOrthopedic ProceduresOrthopedicsAnalgesics, OpioidHumansPain MeasurementPostoperative PainQuality of LifeRandomized Controlled Trials as TopicAnalgesics, OpioidElective surgeryOpioid crisisPain management

Identifiers

PMID33485328
PMCPMC7824925
OpenAlexW3125291747

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.