Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery

Phase 4 Completed 111 enrolled Cedars-Sinai Medical Center

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of the study is to evaluate whether being randomized to an aggressive postoperative non-narcotic pain regimen that treats pain from multiple different pathways may decrease postoperative pain levels, decrease constipation, and decrease the dependency on opioid medications after anorectal surgery versus the standard of care for managing pain. This use of a more aggressive pain regimen is considered an enhanced recovery after surgery (ERAS) protocol because it is theorized to improve or "enhance" postoperative recovery by both decreasing the use of narcotics and their detrimental effects as well as increasing the benefit of using additional non-narcotic pain medication.

Timeline

Start: 2018-10-26
Primary completion: 2022-08-18
Completion: 2022-08-18

Outcome

Met primary endpoint

paper higher among patients in the non-enhanced recovery protocol arm (79 mg; range, 0-600) than patients in the enhanced recovery protocol arm (8 mg; range, 0-390; p = 0.002). PMID 39016381 ↗

Publications

Yao LY, Parrish AB, Fleshner PR, Zaghiyan KN. Implementation of a Multimodal Enhanced Recovery Protocol in Ambulatory Anorectal Surgery: A Randomized Trial. Dis Colon Rectum. 2024 Oct 1;67(10):1304-1312. doi: 10.1097/DCR.0000000000003435. Epub 2024 Jul 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	1000 mg	Oral
Subject	Gabapentin	Unknown	300 mg	Oral
Background	Ketorolac	Other / unclassified	10 mg	Oral
Subject	polyethylene glycol	Other / unclassified	—	—
Background	Benzocaine	Small molecule	—	—
Background	Dexamethasone	Small molecule	—	Oral
Background	Ketorolac	Other / unclassified	—	Intravenous
Background	Oxycodone	Other / unclassified	5 mg	Oral