A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02044302
Recruitment Status : Terminated
First Posted : January 23, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Information provided by (Responsible Party):
Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Post-operative Pain
Interventions: Drug: Bupivacaine
Drug: Botulinum Toxins
Drug: Analgesics

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Blinded Group A No text entered.
Blinded Group B No text entered.

Participant Flow:   Overall Study
    Blinded Group A   Blinded Group B
STARTED   2   0 
COMPLETED   0   0 
study terminated                2                0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only two subjects were enrolled into 1 of the 2 blinded arms and then the study was terminated.

Reporting Groups
Blinded Group A No text entered.
Blinded Group B No text entered.
Total Total of all reporting groups

Baseline Measures
   Blinded Group A   Blinded Group B   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   0   2 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%   0      0   0.0% 
Between 18 and 65 years      2 100.0%   0      2 100.0% 
>=65 years      0   0.0%   0      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      2 100.0%   0      2 100.0% 
Male      0   0.0%   0      0   0.0% 

  Outcome Measures

1.  Primary:   Pain Score Questionnaire   [ Time Frame: Post Operation Day 1 ]

2.  Secondary:   Pain Score Questionnaire   [ Time Frame: Post Operation Week 1 ]

3.  Secondary:   Pain Score Questionnaire   [ Time Frame: Post Operation One Month ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Katisha Brown CPC
Organization: Yale Center for Clinical Investigations
phone: (203) 737-7495

Responsible Party: Yale University Identifier: NCT02044302     History of Changes
Other Study ID Numbers: 1304011938
First Submitted: January 21, 2014
First Posted: January 23, 2014
Results First Submitted: August 26, 2016
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017