CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 111 enrolled
Drug / intervention
ERAS +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03738904
NCT03738904Phase 4Completed

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

Cedars-Sinai Medical Center·interventional·Posted Nov 13, 2018·Updated Dec 18, 2023

In Brief

A Phase 4 clinical trial evaluating ERAS and Standard of care for Anorectal Disorder. Completed, enrolled 111 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedNov 13, 2018
Enrollment StartOct 26, 2018
Primary CompletionAug 18, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.6 years ago

Interventions

ERAScombination

Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol

Standard of carecombination

Oxcodone PO Ketorolac IV only (intraop)