Shing, Elaine Z. https://orcid.org/0000-0002-1469-0925
Leas, Daniel
Michalek, Caleb
Wally, Meghan K.
Hamid, Nady
Funding for this research was provided by:
Duke Endowment
Article History
Received: 30 September 2020
Accepted: 11 January 2021
First Online: 23 January 2021
Ethics approval and consent to participate
: This study received ethics approval by two local institutional review boards: Chesapeake IRB and Presbyterian Healthcare IRB (operated by Novant Health). These approvals covered all sites involved in the study. Eligible patients were approached for informed consent by the physician and research staff. Patients watched an introductory video explaining the purpose of the clinical trial. The physician also led an in-depth preoperative discussion explaining each approach to analgesia (opioid vs. opioid-free) and postoperative expectations. Consent was either then obtained for the study, or if patients declined to participate in the randomized trial, they were presented with the option of enrolling in the observational group where they would be able to select either the control opioid-containing arm or the opioid-free arm. There were no restrictions on patient care due to enrollment in the study.
: Not applicable.
: The authors declare that they have no competing interests.