Aurora, Colorado 80045

  • Pain Control in Postmastectomy Breast Reconstruction With Tissue Expanders

Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

08-0782


NCT ID:

NCT01765309


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:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


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:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Sing


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

23


Enrollment Type:

Actual


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: ClinicalTrials.gov

Date Processed: July 27, 2021

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