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Effects of Pregabalin on Pain After Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01333956
First received: April 8, 2011
Last updated: April 12, 2016
Last verified: April 2016
Results First Received: July 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Primary Total Knee Arthroplasty
Interventions: Drug: Pregabalin 50mg
Drug: Pregabalin 100mg
Drug: Pregabalin 150mg
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
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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
Control

Patients will receive 0mg of pregabalin

Placebo: Patients will receive placebo drug with no active ingredients per dose.

50mg Arm Patients will receive 50mg of pregabalin per dose.
100mg Arm Patients will receive 100mg of pregabalin per dose.
150mg Arm Patients will receive 150mg of pregabalin per dose.

Participant Flow:   Overall Study
    Control     50mg Arm     100mg Arm     150mg Arm  
STARTED     30     30     30     30  
COMPLETED     28     26     29     28  
NOT COMPLETED     2     4     1     2  
Lost to Follow-up                 1                 2                 0                 1  
Unable to complete study procedure                 1                 0                 0                 1  
Withdrawal by Subject                 0                 2                 1                 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.
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Reporting Groups
  Description
Control

Patients will receive 0mg of pregabalin

Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

50mg Arm

Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

100mg Arm

Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

150mg Arm

Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Total Total of all reporting groups

Baseline Measures
    Control     50mg Arm     100mg Arm     150mg Arm     Total  
Number of Participants  
[units: participants]
  30     30     30     30     120  
Age  
[units: years]
Mean (Standard Deviation)
  65.5  (9.8)     66.8  (6.3)     65.1  (7.1)     67.7  (8.1)     66.3  (7.9)  
Gender  
[units: participants]
         
Female     14     18     13     23     68  
Male     16     12     17     7     52  
Region of Enrollment  
[units: participants]
         
United States     30     30     30     30     120  
Body Mass Index (BMI)  
[units: kg/m ^ 2]
Mean (Standard Deviation)
  32  (5)     32  (6)     32  (6)     30  (7)     31.5  (2.45)  



  Outcome Measures
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1.  Primary:   Postoperative Pain   [ Time Frame: 2 weeks postoperatively ]

2.  Secondary:   Opioid-Related Symptom Distress Score   [ Time Frame: 2 weeks postoperatively ]

3.  Secondary:   Self-assessed Sedation and Confusion   [ Time Frame: 1 day postoperatively ]

4.  Secondary:   Numeric Rating Scale (NRS)   [ Time Frame: 3 months ]

5.  Secondary:   Neuropathic Pain   [ Time Frame: 3 months ]

6.  Secondary:   Opioid Usage   [ Time Frame: 3 months ]

7.  Secondary:   Satisfaction   [ Time Frame: 2 weeks ]


  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. Jacques YaDeau
Organization: Hospital for Special Surgery
phone: 212-606-1206
e-mail: yadeauj@hss.edu


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

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01333956     History of Changes
Other Study ID Numbers: 11043
Study First Received: April 8, 2011
Results First Received: July 21, 2015
Last Updated: April 12, 2016
Health Authority: United States: Institutional Review Board