The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial
Authors: Raymond Britany L. , Allen Brian F. S. , Freundlich Robert E. , Parrish Crystal G. , Jayaram Jennifer E. , Wanderer Jonathan P. , Rice Todd W. , Lindsell Christopher J. , Scharfman Kevin H. , Dear Mary L. , Gao Yue , Hiser William D. , McEvoy Matthew D. ,   for the Vanderbilt Learning Healthcare System Platform Investigators, Bernard Gordon R. , Dittus Robert S. , Dwyer Shon , Embí Peter J. , Fitzgerald Chad , Gatto Cheryl L. , Harrell Frank E. , Harris Paul A. , Hartert Tina , Hayman Jim , Ivory Catherine H. , Kleinpell Ruth , Kripalani Sunil , Liska Lee Ann , Luther Patrick , Morrison Jay , Nantais Thomas , Pulley Jill M. , Rehm Kris , Rothman Russell L. , Runyan Patti , Self Wesley H. , Semler Matthew W. , Steaban Robin , Stone Cosby A. , Walker Philip D. , Wilkins Consuelo H. , Wright Adam , Zuckerman Autumn D. 
Published: June 2023

Background

Multimodal analgesic strategies that reduce perioperative opioid consumption are well-supported in Enhanced Recovery After Surgery (ERAS) literature. However, the optimal analgesic regimen has not been established, as the contributions of each individual agent to the overall analgesic efficacy with opioid reduction remains unknown. Perioperative ketamine infusions can decrease opioid consumption and opioid-related side effects. However, as opioid requirements are drastically minimized within ERAS models, the differential effects of ketamine within an ERAS pathway remain unknown. We aim to pragmatically investigate through a learning healthcare system infrastructure how the addition of a perioperative ketamine infusion to mature ERAS pathways affects functional recovery.

Methods

The IMPAKT ERAS trial (IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery) is a single center, pragmatic, randomized, blinded, placebo-controlled trial. 1544 patients undergoing major abdominal surgery will be randomly allocated to receive intraoperative and postoperative (up to 48 h) ketamine versus placebo infusions as part of a perioperative multimodal analgesic regimen. The primary outcome is length of stay, defined as surgical start time until hospital discharge. Secondary outcomes will include a variety of in-hospital clinical end points derived from the electronic health record.

Discussion

We aimed to launch a large-scale, pragmatic trial that would easily integrate into routine clinical workflow. Implementation of a modified consent process was critical to preserving our pragmatic design, permitting an efficient, low-cost model without reliance on external study personnel. Therefore, we partnered with leaders of our Investigational Review Board to develop a novel, modified consent process and shortened written consent form that would meet all standard elements of informed consent, yet also allow clinical providers the ability to recruit and enroll patients during their clinical workflow. Our trial design has created a platform for subsequent pragmatic studies at our institution.

Trial registration

NCT04625283, Pre-results.