Aurora, Colorado 80045

  • Pain Control in Postmastectomy 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.


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

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

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

Overall Status:


Study Phase:




Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Intervention Model: Sing

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Joyce K Aycock, MD
Principal Investigator
University of Colorado, Denver

Study Dates

Start Date:March 2009
Completion Date:July 2012
Completion Type:Actual
Primary Completion Date:July 2012
Primary Completion Type:Actual
Verification Date:March 2012
Last Changed Date:January 9, 2013
First Received Date:January 8, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Difference between preoperative and postoperative pain scale
Time Frame:12 weeks
Safety Issues:False
Description:Patients reported pain in each breast on a visual analog scale of 1-10 at each clinic visit

Study Interventions

Intervention Type:Procedure
Name:Bilateral mastectomy with reconstruction
Description: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
Arm Name:Bilateral mastectomy with reconstruction
Other Name:Botulinum toxin (botox) injection

Study Arms

Study Arm Type:Experimental
Arm Name:Bilateral mastectomy with reconstruction
Description:The trial was a comparison between each breast in a single patient undergoing bilateral mastectomy with reconstruction

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: July 27, 2021

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