eP433 - Opioid versus Opioid-Free Analgesia After Laparoscopic Colorectal Surgery: Protocol for a Placebo-Controlled Pilot Randomized Controlled Trial

Sunday, June 2, 2024

1:39 PM – 1:44 PM ET, USA

Location: Baltimore Convention Center, Room 318-320

ePoster Presenter(s)

Makena Pook, PhD(c) (they/them/theirs)

Doctoral Student
McGill University
McGill University
Montreal, QC, Canada

All of the relevant financial relationships listed below have been mitigated.
This individual has no financial relationships with ineligible companies.

Author(s)

SS

Samin Shirzadi, MD, MPH

Research Assistant
Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada

Disclosure information not submitted.
TN

Tahereh Najafi, n/a

Researcher
Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, QC, Canada.
Montreal, Quebec, Canada

Disclosure information not submitted.
PK

Pepa Kaneva, MSc

Research Assistant
McGill University
Montreal, Quebec, Canada

Disclosure information not submitted.
LF

Liane Feldman, MD

Professor of Surgery
McGill University
montreal, Quebec, Canada

Disclosure information not submitted.
MB

Marylise Boutros, MD (she/her/hers)

Professor of Surgery
Dr Marylise Boutros - Colorectal Surgeon, Cleveland Clinic Florida Professor of Surgery, McGill University, Montreal, Canada
McGill University
Weston, Florida, United States

All relevant financial disclosures have been managed and will be listed below.
This individual has no relevant relationships with ineligible companies.
LL

Lawrence Lee, MD PhD

Associate Professor of Surgery
McGill University Health Centre
Montreal, Quebec, Canada

Disclosure information not submitted.
JF

Julio F. Fiore Jr, PhD

Assistant Professor
McGill University
Montreal, Quebec, Canada

Disclosure information not submitted.

Purpose/Background: Postoperative opioid overprescribing is an important contributor to the opioid crisis. Colorectal surgery patients are frequently prescribed opioids to manage postoperative pain, however, evidence regarding the comparative-effectiveness of opioid analgesia (OA) versus opioid-free analgesia (OFA) after colorectal surgery remains scarce. Thus, this study will investigate the feasibility of conducting a full-scale randomized controlled trial (RCT) to estimate the extent to which a postoperative OA regimen impacts patient-reported pain in comparison to an OFA regimen after laparoscopic colorectal surgery.Methods/Interventions: This will be a multicenter, parallel, two-group, double-blind, placebo-controlled, pilot RCT. Analysis and reporting will follow the CONSORT extension for pilot trials. Patients (≥18 years) undergoing elective inpatient laparoscopic colorectal surgery at the Montreal General Hospital (MGH) or Jewish General Hospital (JGH) in Montreal, Quebec, Canada will be included. Participants will be randomly allocated (1:1) to receive OA or OFA during their hospital stay and after discharge. Randomization will be stratified by study site (MGH/JGH) and stoma formation (yes/no). Participants allocated to OA will receive around-the-clock non-opioids (i.e., acetaminophen 1000mg every 6 hours and celecoxib 100-200mg twice per day) and opioids (i.e., oxycodone 5mg up to four times per day) ‘as needed’ for breakthrough pain. Participants allocated to OFA will receive around-the-clock non-opioids (i.e., same regimen as OA group) and placebo for breakthrough pain. All participants will be instructed by the research team on Cryotherapy (i.e., cold packs) use for uncontrolled pain. Patient-reported outcomes and treatment adherence data will be collected via electronic questionnaires. In accordance with an a priori power calculation, we will target a sample of 80 participants (40 per group, ~15% attrition rate) to ensure an acceptable degree of precision around feasibility estimates.Results/Outcomes: The primary outcome of this study will be the feasibility of conducting a full-scale RCT, assessed via recruitment rate, treatment adherence, and rates of missing follow-up data. Secondary clinical outcomes will include pain intensity and interference (Brief Pain Inventory), analgesic intake, drug adverse events, and 30-day unplanned health care utilization.Conclusion/

Discussion: Alternatives to opioids are often overlooked by North American colorectal surgeons, while they should be incorporated as the foundation of postoperative analgesia whenever possible. This pilot RCT is an essential first step towards future definitive trials to inform evidence-based analgesia prescribing and potentially mitigate opioid-related harms after colorectal surgery.