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The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00620828
First received: February 12, 2008
Last updated: March 19, 2013
Last verified: March 2013
Results First Received: June 17, 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: Supportive Care
Condition: Osteoarthritis
Interventions: Other: Placebo saline injection
Drug: Ropivicaine 0.5%

  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
12 of the 79 subjects enrolled were screening failures, thus total number of subjects completing the study = 67. One patient had staged bilateral TKA so there are 66 total patients, but 67 injections given.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
12 of the 79 subjects enrolled were screening failures

Reporting Groups
  Description
Control Group Subjects receive intra-op saline injection per protocol
Block Group Subjects receive intra-op Ropivicaine 0.5% injection per protocol

Participant Flow:   Overall Study
    Control Group     Block Group  
STARTED     32     35  
Number of Subjects Enrolled = 67     32     35  
COMPLETED     32     35  
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.
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Reporting Groups
  Description
Control Group Subjects receive intra-op saline injection per protocol
Block Group Subjects receive intra-op Ropivicaine 0.5% injection per protocol
Total Total of all reporting groups

Baseline Measures
    Control Group     Block Group     Total  
Number of Participants  
[units: participants]
  32     35     67  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     8     14  
>=65 years     26     27     53  
Age  
[units: years]
Mean ± Standard Deviation
  65.4  ± 2     66.9  ± 2     66.1  ± 2  
Gender  
[units: participants]
     
Female     24     20     44  
Male     8     15     23  
Region of Enrollment  
[units: participants]
     
United States     32     35     67  
Lean Body Weight  
[units: kg]
Mean ± Standard Deviation
  59.9  ± 12.4     62.9  ± 11.1     61.4  ± 11.75  



  Outcome Measures
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1.  Primary:   Numeric Pain Score   [ Time Frame: Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection ]

2.  Secondary:   Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption   [ Time Frame: 4 hours to 24 hours post-op ]

3.  Secondary:   Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance   [ Time Frame: 24 hours post-op ]

4.  Secondary:   Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion   [ Time Frame: 24 hours post-op ]

5.  Secondary:   Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise   [ Time Frame: 4 hours, 8 hours, 12 hours and 24 hours post-op ]


  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: Michael Bolognesi, MD
Organization: Duke UMC
phone: 919-668-4732 ext 2
e-mail: bolog002@mc.duke.edu


Publications:


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00620828     History of Changes
Other Study ID Numbers: Pro00000233, SPS# 139715
Study First Received: February 12, 2008
Results First Received: June 17, 2010
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board