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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02044302
First received: January 21, 2014
Last updated: April 6, 2017
Last verified: February 2017
Results First Received: August 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Condition: Post-operative Pain
Interventions: Drug: Bupivacaine
Drug: Botulinum Toxins
Drug: Analgesics

  Participant Flow
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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
  Description
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 
NOT COMPLETED   2   0 
study terminated                2                0 



  Baseline Characteristics
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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
  Description
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 
Age 
[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
  Show All 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
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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
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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
e-mail: katisha.brown@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02044302     History of Changes
Other Study ID Numbers: 1304011938
Study First Received: January 21, 2014
Results First Received: August 26, 2016
Last Updated: April 6, 2017