CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Dexamethasone 4mg +1 moredrug
Likely dose
Dexamethasone 4mgfrom 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/NCT04919317
NCT04919317Phase 2Completed

Enhanced Pain Control After Reduction Mammaplasty With Bupivicaine and Dexamethasone Regional Block: a Double-blind Randomized Controlled Trial

Temple University·interventional·Posted Jun 9, 2021·Updated Oct 11, 2023

In Brief

A Phase 2 clinical trial evaluating Dexamethasone 4mg and Saline for Pain, Postoperative and Mammaplasty. Completed, enrolled 56 participants across 1 site.

Detailed Summary

The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been shown to enhance pain control and prolong the time until first request for postoperative narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been investigated in any types of breast surgery. The investigators assessed if the combination of dexamethasone to bupivacaine in the preoperative field block prior to bilateral breast reduction surgery resulted in improved pain control relative to bupivacaine alone.

Study Details

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

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 9, 2021
Enrollment StartSep 29, 2017
Primary CompletionNov 7, 2020
Study CompletionNov 25, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 5.1 years ago

Interventions

Dexamethasone 4mgdrug

The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.

Salinedrug

The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.