Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy

This study has been completed.
Sponsor:
Information provided by:
Severance Hospital
ClinicalTrials.gov Identifier:
NCT00905580
First received: May 18, 2009
Last updated: January 15, 2010
Last verified: October 2009
Results First Received: October 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Pain, Postoperative
Interventions: Drug: Pregabalin
Drug: Vitamin Complex (placebo)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
Pregabalin Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later

Participant Flow:   Overall Study
    Placebo     Pregabalin  
STARTED     49     50  
COMPLETED     47     47  
NOT COMPLETED     2     3  



  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.
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Reporting Groups
  Description
Placebo Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
Pregabalin Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Total Total of all reporting groups

Baseline Measures
    Placebo     Pregabalin     Total  
Number of Participants  
[units: participants]
  49     50     99  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     49     50     99  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.5  ± 9.5     38.0  ± 8.2     38.2  ± 8.9  
Gender  
[units: participants]
     
Female     46     48     94  
Male     3     2     5  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     49     50     99  



  Outcome Measures
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1.  Primary:   Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.   [ Time Frame: 1, 6, 24 & 48 hours ]

2.  Primary:   The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.   [ Time Frame: 1, 6, 24 & 48 hours ]

3.  Primary:   Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively   [ Time Frame: 1, 6, 24 & 48 hours ]

4.  Secondary:   Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.   [ Time Frame: 3 months ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. So Yeon Kim
Organization: Department of Anaesthesiology and Pain Medicine and Anaesthesia and Pain Research Institute, Department of surgery, Yonsei University College of Medicine
phone: 82-2-2227-3642
e-mail: kimsy326@hanmail.net


No publications provided by Severance Hospital

Publications automatically indexed to this study:

Responsible Party: Severance Hospital, Anesthesia and Pain Research Institute
ClinicalTrials.gov Identifier: NCT00905580     History of Changes
Other Study ID Numbers: IRB 4-2009-0070
Study First Received: May 18, 2009
Results First Received: October 13, 2009
Last Updated: January 15, 2010
Health Authority: Korea: Food and Drug Administration