drugset / Trial / NCT03738904

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

NCT03738904

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1000 mg Oral
Subject Gabapentin Small molecule 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

Indications