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Liposomal Bupivacaine in Simultaneous Bilateral Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02349542
Recruitment Status : Completed
First Posted : January 29, 2015
Results First Posted : August 2, 2017
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Arthroplasty, Replacement, Knee
Pain
Intervention Drug: Liposomal bupivacaine
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liposomal Bupivacaine
Hide Arm/Group Description

Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.

Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.

Period Title: Overall Study
Started 20
Completed [1] 15
Not Completed 5
Reason Not Completed
Withdrawal by Subject             5
[1]
Patients were withdrawn from the study if they did not schedule surgery or canceled their surgery.
Arm/Group Title Liposomal Bupivacaine
Hide Arm/Group Description

Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.

Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
60
(57 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
 100.0%
Body Mass Index  
Mean (Full Range)
Unit of measure:  Kilograms per meters-squared
Number Analyzed 15 participants
30.7
(27 to 34.9)
1.Primary Outcome
Title Adverse Events
Hide Description Number of Participants with Adverse Events
Time Frame Up to 72 hours following injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liposomal Bupivacaine
Hide Arm/Group Description:

Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.

Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.

Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Plasma Bupivacaine Levels
Hide Description Blood samples will be drawn and analyzed to establish levels of bupivacaine detectable in the blood. Blood samples will be drawn at baseline (prior to injection), upon injection, at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours post-injection and analyzed to determine levels of bupivacaine present.
Time Frame Up to 72 hours following injection
Hide Outcome Measure Data
Hide Analysis Population Description
Blood draws were collected at the pre-defined intervals unless the patient was discharged prior to the blood collection time. 6 patients were discharged prior to the 48 hour collection time. 5 additional patients were discharged prior to the 72 hour collection time.
Arm/Group Title Liposomal Bupivacaine
Hide Arm/Group Description:

Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.

Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: ug/ml
Baseline (Pre-Injection) Number Analyzed 15 participants
0  (0)
Immediately Following Injection Number Analyzed 15 participants
0.22  (0.25)
15 minutes after injection Number Analyzed 15 participants
0.31  (0.25)
30 minutes after injection Number Analyzed 15 participants
0.35  (0.21)
1 hour after injection Number Analyzed 15 participants
0.47  (0.21)
2 hours after injection Number Analyzed 15 participants
0.53  (0.21)
4 hours after injection Number Analyzed 15 participants
0.56  (0.26)
8 hours after injection Number Analyzed 15 participants
0.63  (0.20)
12 hours after injection Number Analyzed 15 participants
0.56  (0.25)
24 hours after injection Number Analyzed 15 participants
0.71  (0.22)
48 hours after injection Number Analyzed 9 participants
0.80  (0.37)
72 hours after injection Number Analyzed 4 participants
0.43  (0.22)
Time Frame Patients were followed for adverse events through the 6-week follow-up visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liposomal Bupivacaine
Hide Arm/Group Description

Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.

Liposomal bupivacaine: One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.

All-Cause Mortality
Liposomal Bupivacaine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Liposomal Bupivacaine
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liposomal Bupivacaine
Affected / at Risk (%)
Total   0/15 (0.00%) 
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: Senior Research Scientist
Organization: OrthoCarolina Research Institute
Phone: 704-323-2260
Publications:
Hutchinson RW, Chon EH, Gilder R, Moss J, Daniel P. A comparison of a fentanyl, morphine, and hydromorphone patient-controlled intravenous delivery for acute postoperative analgesia: a multicenter study of opioid-induced adverse reactions. Hospital Pharmacy 41(7): 659-663, 2006.
Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02349542     History of Changes
Other Study ID Numbers: 11-14-10B
First Submitted: January 16, 2015
First Posted: January 29, 2015
Results First Submitted: July 7, 2017
Results First Posted: August 2, 2017
Last Update Posted: August 31, 2017