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Pregabalin for the Treatment of Pain After Posterior Spinal Fusions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01366196
First Posted: June 3, 2011
Last Update Posted: June 21, 2017
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 (Responsible Party):
Hospital for Special Surgery, New York
Results First Submitted: March 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lumbar Spinal Fusions
Interventions: Drug: Pregabalin 150 mg
Drug: 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
No text entered.

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
Control Group (C) Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
Pregabalin Group (P) Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.

Participant Flow:   Overall Study
    Control Group (C)   Pregabalin Group (P)
STARTED   43   43 
COMPLETED   43   43 
NOT COMPLETED   0   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
Control Group (C) Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
Pregabalin Group (P) Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
Total Total of all reporting groups

Baseline Measures
   Control Group (C)   Pregabalin Group (P)   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   43   86 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.186  (12.599)   57.511  (13.491)   56.849  (12.993) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      22  51.2%      22  51.2%      44  51.2% 
Male      21  48.8%      21  48.8%      42  48.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   43   43   86 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Patient Controlled Analgesia (PCA) Hydromorphone Usage   [ Time Frame: Postoperative day 1 ]

2.  Secondary:   Oral Analgesic Supplementation Use   [ Time Frame: Day of surgery ]


  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. Michael Urban
Organization: Hss
phone: (212) 606-1000
e-mail: UrbanM@hss.edu


Publications:

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01366196     History of Changes
Other Study ID Numbers: IRB #27092
First Submitted: June 2, 2011
First Posted: June 3, 2011
Results First Submitted: March 23, 2017
Results First Posted: June 21, 2017
Last Update Posted: June 21, 2017



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