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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01765309

Enrollment

Registered

2013-01-10

Start date

2009-03-31

Completion date

2012-07-31

Last updated

2013-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Tissue expanders, Botulinum toxin, Botox

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.

Interventions

PROCEDUREBilateral mastectomy with reconstruction

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Bilateral mastectomy with immediate tissue expander reconstruction

Exclusion criteria

* Unwilling to receive study injections

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026