CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,570 enrolled
Drug / intervention
Ketamine +1 moredrug
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/NCT04625283
NCT04625283Phase 4Completed

The Effect and Contribution of a Perioperative Ketamine Infusion in an Established Enhanced Recovery Pathway

Vanderbilt University Medical Center·interventional·Posted Nov 12, 2020·Updated Feb 4, 2025

In Brief

A Phase 4 clinical trial evaluating Ketamine and Placebo for Opioid Use and 4 related conditions. Completed, enrolled 1,570 participants across 1 site.

Detailed Summary

In order to effectively treat surgical pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. In light of the opioid epidemic, medical providers at Vanderbilt University Medical Center (VUMC) are strategically combining these medications in a bundled pain-regimen after surgery. These regimens have been shown to decrease opioid consumption, improve surgical outcomes, and reduce hospital stays, thus coining the term 'enhanced recovery pathway'. The combination of these medications has an indisputable synergistic effect. However, it is unknown how each medication contributes individually to the overall efficacy of the pathway. This study will examine the effects of ketamine, within the constructs of a multimodal pain regimen, on a) length of stay, b) opioid consumption, and c) surgical outcomes after major abdominal surgery.

Study Details

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

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedNov 12, 2020
Enrollment StartApr 12, 2021
Primary CompletionJan 26, 2024
Study CompletionFeb 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.6 years ago

Interventions

Ketaminedrug

Participants in the ketamine arm will receive intraoperative and postoperative ketamine.

Placebodrug

Participants in the placebo arm will receive intraoperative and postoperative saline.