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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Bilateral mastectomy with reconstruction

• Registration Number: NCT01765309
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Status Verified: 2012-03
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-10
• Last Update Submitted: 2013-01-10
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

• Bilateral mastectomy with immediate tissue expander reconstruction

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Exclusion Criteria

• Unwilling to receive study injections

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bilateral mastectomy with reconstruction	Bilateral mastectomy with reconstruction	The trial was a comparison between each breast in a single patient undergoing bilateral mastectomy with reconstruction

Primary Outcome Measures

Name	Time	Method
Difference between preoperative and postoperative pain scale	12 weeks	Patients reported pain in each breast on a visual analog scale of 1-10 at each clinic visit

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States