A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders

University of Colorado, Denver23 enrolled

Overview

Investigation of whether injection of the pectoralis muscle with 100 units botulinum toxin during breast reconstruction with tissue expanders results in decreased pain using a blinded, randomized, controlled trial.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Breast Cancer

Interventions

Bilateral mastectomy with reconstructionPROCEDURE

In each patient enrolled in the study, botulinum toxin was injected into one pectoralis muscle while saline placebo was injected on the opposite side in a randomized blinded fashion

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Bilateral mastectomy with immediate tissue expander reconstruction Exclusion Criteria: * Unwilling to receive study injections

Locations (1)

University of Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Difference between preoperative and postoperative pain scale

Patients reported pain in each breast on a visual analog scale of 1-10 at each clinic visit

Time frame: 12 weeks

Data from ClinicalTrials.gov

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