Managing perioperative pain with abdominal laparoscopic surgery: a collaborative to develop, disseminate, and evaluate evidence-based practices (m-pals collaborative)

This $1,999,999 Cooperative Agreement awarded by the Center for Drug Evaluation and Research (CDER), part of the U.S. Food and Drug Administration (CFDA 93.103 Food and Drug Administration Research), will support the development, dissemination, and evaluation of an evidence-based clinical practice guideline for managing perioperative pain associated with abdominal laparoscopic surgeries. The project, titled "Managing Perioperative Pain with Abdominal Laparoscopic Surgery: A Collaborative to Develop, Disseminate, and Evaluate Evidence-Based Practices (M-PALS Collaborative)", aims to address the public health crisis of opioid dependence by providing guidance to improve pain management and minimize opioid use in this common surgical population. The award recipient, Regents of the University of Minnesota, will leverage their expertise and collaborate with the University of California, San Francisco to conduct this work over a 3-year period starting on September 25, 2023.

Abstract

Dependence on prescription opioids is a public health crisis affecting millions of people in the U.S. Evidence- based clinical guidance is critical for managing pain while reducing the risk of opioid use disorder (OUD), but there is a lack of guidance for managing acute pain associated with abdominal laparoscopic (including robotic) surgeries, which is the preferred and growing technique for a vast number of abdominal surgeries (e.g. cholecystectomy, bowel obstruction, appendectomy, colon and rectal surgery, etc.). The project, managing perioperative pain after abdominal laparoscopic surgery: a collaborative to develop, disseminate, and evaluate evidence-based practices (m-pals collaborative) will develop a clinical-practice guideline (CPG) with interdisciplinary stakeholders and subject matter experts, and then translate and evaluate this CPG in practice. We hypothesize this up-to-date and comprehensive CPG and subsequent implementation and dissemination will result in superior pain management and minimized use of opioids, as well as decreased rates of OUD after abdominal laparoscopic surgery (especially in opiate naive patients), and similarly improved patient satisfaction and pain management metrics. To account for variability by region and differences in surgical workflow by practice setting, we ensure broad applicability by conducting our work at m health fairview (UMN, a collaboration of the UMN medical school, univ of MN physicians, and fairview health services) and the university of california, SAN francisco across distinct and diverse patient populations. Aim 1: in collaboration with the FDA and guided by MN-EPC, develop a laparoscopic abdominal surgical pain management CPG. We will leverage and extend the national academy of sciences, engineering, and medicine (nasem) framework on acute pain management, convene multidisciplinary expert stakeholders, and guide CPG development to address abdominal laparoscopic surgical populations and perspectives on unmet needs, including disparities in pain management. Aim 2: implement and disseminate the CPG. Core activities cover CPG acceptance, academic dissemination, website materials, LHS learning communities to enhance/scale, EHR tool CPG implementation (including CDS) via a stepped-wedge design, and an EHR-vendor clinical program to share tools across organizations. Aim 3: evaluate and assess the CPG including adoption, feedback on facilitators and barriers, and outcomes. Assess primary (CPG adherence, pain scores, opioid use) and secondary outcomes guided by RE-aim; evaluate implementation (e.g., study strategies, system factors, stakeholder engagement) guided by epis. This project is significant, innovative, and feasible, applying rigorous CPG development, extending nasem report frameworks, utilizing novel LHS approaches in CPG implementation, and leveraging a transdisciplinary expert team with a track record of successful collaboration and health system-embedded research.