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Opioid-free Analgesia After Outpatient General Surgery: A Pilot Randomized Controlled Trial

ClinicalTrials.gov · COMPLETED, 2020

81 participants

Abstract

North America is facing an opioid epidemic fueled by surgeons, who are the second largest subgroup of physicians involved in opioid prescribing. Surgery often serves as the initial event for opioid-naïve patients to obtain a prescription for opioids and spiral into misuse and addiction. From the perspective of perioperative care clinicians, the answer to the opioid crisis may be using opioid-free analgesia. However, the number of comparative studies in this field is limited and existing small trials do not reflect current standards of care in North America. Lack of evidence means that the decision to prescribe opioids after outpatient surgery largely depends on surgeon preference and healthcare culture. Hence, there is an urgent need for a robust randomized controlled trial (RCT) to guide clinical decision-making. The feasibility and optimal design of this RCT should be informed by a pilot trial. The overarching goal of this pilot RCT is to investigate the feasibility of conducting a full-scale RCT to assess the comparative-effectiveness of opioid versus opioid-free analgesia after outpatient general surgery.

Conditions: Outpatient Surgery, Abdominal Surgery, Breast Surgery.

Primary outcome: Percentage of Screened Participants Who Were Eligible to Participate in the Study; Percentage of Surgeons Agreeing and Adhering to Patient Randomization; Percentage of Eligible Patients Agreeing to Participate; Percentage of Randomized Patients Complying With Allocated Treatment;…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 81 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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