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Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle Kinney, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588159
First received: December 18, 2007
Last updated: March 29, 2016
Last verified: March 2016
Results First Received: December 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Gabapentin
Drug: Diphenhydramine

  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
Gabapentin Preoperatively Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
Active Placebo Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.

Participant Flow:   Overall Study
    Gabapentin Preoperatively   Active Placebo
STARTED   72   74 
COMPLETED   57   63 
NOT COMPLETED   15   11 



  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
Gabapentin Preoperatively Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
Active Placebo Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Total Total of all reporting groups

Baseline Measures
   Gabapentin Preoperatively   Active Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 72   74   146 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   33   38   71 
>=65 years   39   36   75 
Age 
[Units: Years]
Mean (Standard Deviation)
 64  (7)   64  (7)   64  (7) 
Gender 
[Units: Participants]
     
Female   32   38   70 
Male   40   36   76 
Region of Enrollment 
[Units: Participants]
     
United States   72   74   146 


  Outcome Measures
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1.  Primary:   Average Pain Score at Rest   [ Time Frame: 48 hours ]

2.  Primary:   Average Pain Score With Coughing the First Morning Following Surgery   [ Time Frame: First morning following surgery ]

3.  Primary:   Average Pain Score With Coughing on Second Morning After Surgery   [ Time Frame: Second morning after surgery ]

4.  Secondary:   Opioid Consumption in First 24 Hours Postoperatively   [ Time Frame: 24 hours ]

5.  Secondary:   Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively   [ Time Frame: 3 months postoperatively ]

6.  Secondary:   Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively   [ Time Frame: 48 hours postoperatively ]


  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: Dr. Michelle A. O. Kinney
Organization: Mayo Clinic
phone: 507-266-9877
e-mail: kinney.michelle@mayo.edu


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

Responsible Party: Michelle Kinney, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588159     History of Changes
Other Study ID Numbers: 05-004145
Study First Received: December 18, 2007
Results First Received: December 28, 2010
Last Updated: March 29, 2016
Health Authority: United States: Institutional Review Board