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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905580
First Posted: May 20, 2009
Last Update Posted: January 20, 2010
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.
Information provided by:
Severance Hospital
Results First Submitted: October 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, 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 
Overall Participants Analyzed 
[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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Severance Hospital, Anesthesia and Pain Research Institute
ClinicalTrials.gov Identifier: NCT00905580     History of Changes
Other Study ID Numbers: IRB 4-2009-0070
First Submitted: May 18, 2009
First Posted: May 20, 2009
Results First Submitted: October 13, 2009
Results First Posted: January 11, 2010
Last Update Posted: January 20, 2010