Postoperative Pain and Morphine Consumption After Mastectomy - Lyrica

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Babatunde Ogunnaike, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01391858
First received: June 27, 2011
Last updated: August 8, 2014
Last verified: August 2014
Results First Received: December 31, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Post-operative Pain
Intervention: Drug: lyrica

  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
In recent years, surgical techniques have evolved from mastectomy with lymph node dissections to other forms of less invasive or nonsurgical techniques and these changes reduced the number of patients getting an axillary lymph node dissection (personal communication with the study-associated surgeon).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 80 patients were consented. 7 patients did not show up for surgery. Of the 73 patients randomized, only 49 received intervention. The remaining 24 either had their surgery cancelled, withdrew their consent before intervention, or did not receive the loading dose in time to continue with the study.

Reporting Groups
  Description
Pregabalin Pregabalin 300 mg 1-2 hrs. before the surgery and then 150 mg twice a day for 14 days
Placebo Placebo 1-2 hrs. before the surgery and then twice daily for 14 days

Participant Flow:   Overall Study
    Pregabalin     Placebo  
STARTED     25     24  
COMPLETED     23     24  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Pregabalin

pregabalin (lyrica)

lyrica: 150mg of pregabalin/placebo

Placebo

placebo

lyrica: 150mg of pregabalin/placebo

Total Total of all reporting groups

Baseline Measures
    Pregabalin     Placebo     Total  
Number of Participants  
[units: participants]
  23     24     47  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 9     47  ± 8     49  ± 7  
Gender  
[units: participants]
     
Female     23     24     47  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     23     24     47  



  Outcome Measures
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1.  Primary:   The Postoperative Opioid Requirement After Mastectomy   [ Time Frame: Participants received PCA pump, an average of 24 hrs after mastectomy ]

2.  Primary:   Oral Opioids Consumption   [ Time Frame: Participants were followed for the consumption of oral opioid for the duration of hospital stay, an average of 3 days after mastectomy ]

3.  Secondary:   Pain Scores   [ Time Frame: Participants` pain score was assessed on the first postoperative day after mastectomy ]

4.  Secondary:   Pain Scores   [ Time Frame: Participants` pain score was assessed at hospital discharge, an average of 3 days after mastectomy ]

5.  Secondary:   Pain Scores   [ Time Frame: Participants` pain score was assessed after discharge on the 7th day after mastectomy ]

6.  Secondary:   Pain Scores   [ Time Frame: Participants` pain score was assessed after discharge on the 14th day after mastectomy ]

7.  Secondary:   Pain Scores   [ Time Frame: Participants` pain score was assessed after discharge on the 30th day after mastectomy ]

8.  Secondary:   Pain Scores   [ Time Frame: Participants` pain score was assessed after discharge on the 90th day after mastectomy ]


  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: Babatunde Ogunnaike
Organization: UTexas Southwestern Medical Center
phone: (214) 590 ext 8536
e-mail: Babatunde.Ogunnaike@UTSouthwestern.edu


No publications provided


Responsible Party: Babatunde Ogunnaike, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01391858     History of Changes
Obsolete Identifiers: NCT00631891
Other Study ID Numbers: 2004-0643
Study First Received: June 27, 2011
Results First Received: December 31, 2013
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board