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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Bilateral mastectomy with immediate tissue expander reconstruction

Exclusion criteria

Unwilling to receive study injections

Treatment and study plan

Bilateral mastectomy with reconstruction

Procedure

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

Other names: Botulinum toxin (botox) injection

Primary outcomes

Difference between preoperative and postoperative pain scale

Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Jan 10, 2013
Registry last updated: Jan 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed