MedTrace Logo

Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction

NCT02525718 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-08-14

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Saline

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

DRUG

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

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.

Sponsors & Collaborators

Principal Investigators

  • Mohammed Alghoul, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-11-30
Completion
2017-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02525718 on ClinicalTrials.gov