CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Saline +1 moredrug
Likely dose
0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasonefrom 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/NCT02525718
NCT02525718Phase 2Completed
CompareCT.gov

Does Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction Reduce Postoperative Pain and Opioid Requirement?: A Prospective Double-Blinded Randomized Controlled Trial

Northwestern University·interventional·Posted Aug 17, 2015·Updated Aug 14, 2019

In Brief

A Phase 2 clinical trial evaluating Saline and 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone for Breast Cancer. Completed, enrolled 47 participants across 1 site.

Detailed Summary

Subjects are being asked to participate in this study because they will be undergoing unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction involving insertion of a tissue expander.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 17, 2015
Enrollment StartAug 1, 2015
Primary CompletionNov 1, 2016
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.9 years ago

Interventions

Salinedrug

If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)

0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasonedrug

If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine. (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.