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EXPAREL Infiltration in Subjects Undergoing Femoral Nerve Block With Bupivacaine HCl for Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02255500
Recruitment Status : Completed
First Posted : October 2, 2014
Results First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Bupivacaine FNB
Drug: EXPAREL Infiltration
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bupivacaine FNB + EXPAREL Infiltration Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine
Hide Arm/Group Description

Femoral nerve block with bupivacaine hydrochloride (HCl) 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.

Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.

EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.

Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.

Note: Seven subjects received EXPAREL mixed with bupivacaine with epinephrine. The data for these subjects are summarized as a separate arm from "Bupivacaine FNB + EXPAREL Infiltration."

Period Title: Overall Study
Started 16 7
Completed 15 7
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Bupivacaine FNB + EXPAREL Infiltration Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine Total
Hide Arm/Group Description

FNB with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.

Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.

EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.

Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.

Note: Seven subjects received EXPAREL mixed with bupivacaine with epinephrine. The data for these subjects are summarized as a separate arm from "Bupivacaine FNB + EXPAREL Infiltration."

Total of all reporting groups
Overall Number of Baseline Participants 16 7 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 7 participants 23 participants
67.1  (8.61) 59.7  (7.04) 64.9  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 7 participants 23 participants
Female
9
  56.3%
4
  57.1%
13
  56.5%
Male
7
  43.8%
3
  42.9%
10
  43.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 7 participants 23 participants
Hispanic or Latino
3
  18.8%
0
   0.0%
3
  13.0%
Not Hispanic or Latino
13
  81.3%
7
 100.0%
20
  87.0%
Unknown or Not Reported
0
   0.0%
.0
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 7 participants 23 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   6.3%
1
  14.3%
2
   8.7%
White
15
  93.8%
6
  85.7%
21
  91.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 7 participants 23 participants
16 7 23
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description

The maximum observed plasma concentration of a drug in the body after the drug has been administered.

Blood samples for bupivacaine pharmacokinetic (PK) analysis were to be obtained from subjects at baseline (prior to bupivacaine HCl administration for nerve block), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours, and 14 days after the beginning of EXPAREL administration

Time Frame Baseline, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours, and 14 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set includes all subjects who received bupivacaine HCl with epinephrine and EXPAREL, provided sufficient samples to allow for calculation of the PK parameters required for analysis, and did not have significant protocol deviations that might have invalidated or biased the results.
Arm/Group Title Bupivacaine FNB + EXPAREL Infiltration Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine
Hide Arm/Group Description:

FNB with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.

Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.

EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.

Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.

Note: Seven subjects received EXPAREL mixed with bupivacaine with epinephrine. The data for these subjects are summarized as a separate arm from "Bupivacaine FNB + EXPAREL Infiltration."

Overall Number of Participants Analyzed 14 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
499  (148) 775  (299)
2.Primary Outcome
Title Time to Peak Plasma Concentration (Tmax)
Hide Description

The time to reach the maximum observed plasma concentration (Cmax)

Blood samples for bupivacaine PK analysis were to be obtained from subjects at baseline (prior to bupivacaine HCl administration for nerve block), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours, and 14 days after the beginning of EXPAREL administration

Time Frame Baseline, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours, and 14 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set includes all subjects who received bupivacaine HCl with epinephrine and EXPAREL, provided sufficient samples to allow for calculation of the PK parameters required for analysis, and did not have significant protocol deviations that might have invalidated or biased the results.
Arm/Group Title Bupivacaine FNB + EXPAREL Infiltration Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine
Hide Arm/Group Description:

FNB with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.

Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.

EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.

Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.

Note: Seven subjects received EXPAREL mixed with bupivacaine with epinephrine. The data for these subjects are summarized as a separate arm from "Bupivacaine FNB + EXPAREL Infiltration."

Overall Number of Participants Analyzed 14 7
Median (Full Range)
Unit of Measure: hours
0.675
(0.183 to 78.0)
47.450
(0.183 to 72.9)
3.Primary Outcome
Title Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration After Drug Administration (AUC0-last)
Hide Description

Total drug exposure up to the last measurable concentration

Blood samples for bupivacaine PK analysis were to be obtained from subjects at baseline (prior to bupivacaine HCl administration for nerve block), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours, and 14 days after the beginning of EXPAREL administration

Time Frame Baseline, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours, and 14 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set includes all subjects who received bupivacaine HCl with epinephrine and EXPAREL, provided sufficient samples to allow for calculation of the PK parameters required for analysis, and did not have significant protocol deviations that might have invalidated or biased the results.
Arm/Group Title Bupivacaine FNB + EXPAREL Infiltration Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine
Hide Arm/Group Description:

FNB with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.

Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.

EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.

Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.

Note: Seven subjects received EXPAREL mixed with bupivacaine with epinephrine. The data for these subjects are summarized as a separate arm from "Bupivacaine FNB + EXPAREL Infiltration."

Overall Number of Participants Analyzed 14 7
Mean (Standard Deviation)
Unit of Measure: hours*ng/mL
28234  (10710) 46600  (16489)
4.Primary Outcome
Title Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity After Drug Administration (AUC0-∞)
Hide Description

Total drug exposure, extrapolated to infinity

Blood samples for bupivacaine PK analysis were to be obtained from subjects at baseline (prior to bupivacaine HCl administration for nerve block), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours, and 14 days after the beginning of EXPAREL administration

Time Frame Baseline, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours, and 14 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine FNB + EXPAREL Infiltration Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine
Hide Arm/Group Description:

FNB with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.

Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.

EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.

Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.

Note: Seven subjects received EXPAREL mixed with bupivacaine with epinephrine. The data for these subjects are summarized as a separate arm from "Bupivacaine FNB + EXPAREL Infiltration."

Overall Number of Participants Analyzed 6 1
Mean (Standard Deviation)
Unit of Measure: hours*ng/mL
25134  (11506) 38489  (NA)
5.Primary Outcome
Title The Apparent Terminal Elimination Rate Constant (λz)
Hide Description Blood samples for bupivacaine PK analysis were to be obtained from subjects at baseline (prior to bupivacaine HCl administration for nerve block), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours, and 14 days after the beginning of EXPAREL administration
Time Frame Baseline, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours, and 14 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set includes all subjects who received bupivacaine HCl with epinephrine and EXPAREL, provided sufficient samples to allow for calculation of the PK parameters required for analysis, and did not have significant protocol deviations that might have invalidated or biased the results.
Arm/Group Title Bupivacaine FNB + EXPAREL Infiltration Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine
Hide Arm/Group Description:

FNB with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.

Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.

EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.

Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.

Note: Seven subjects received EXPAREL mixed with bupivacaine with epinephrine. The data for these subjects are summarized as a separate arm from "Bupivacaine FNB + EXPAREL Infiltration."

Overall Number of Participants Analyzed 6 1
Mean (Standard Deviation)
Unit of Measure: 1/hours
0.0290  (0.0089) .0315  (NA)
6.Primary Outcome
Title The Apparent Terminal Elimination Half-life (t1/2el)
Hide Description Blood samples for bupivacaine PK analysis were to be obtained from subjects at baseline (prior to bupivacaine HCl administration for nerve block), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours, and 14 days after the beginning of EXPAREL administration
Time Frame Baseline, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours, and 14 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set includes all subjects who received bupivacaine HCl with epinephrine and EXPAREL, provided sufficient samples to allow for calculation of the PK parameters required for analysis, and did not have significant protocol deviations that might have invalidated or biased the results.
Arm/Group Title Bupivacaine FNB + EXPAREL Infiltration Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine
Hide Arm/Group Description:

FNB with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.

Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.

EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.

Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.

Note: Seven subjects received EXPAREL mixed with bupivacaine with epinephrine. The data for these subjects are summarized as a separate arm from "Bupivacaine FNB + EXPAREL Infiltration."

Overall Number of Participants Analyzed 6 1
Mean (Standard Deviation)
Unit of Measure: hours
25.9  (8.02) 22  (NA)
Time Frame Adverse events were to be monitored from the time the informed consent form was signed through Day 14 post-dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupivacaine FNB + EXPAREL Infiltration Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine
Hide Arm/Group Description

FNB with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.

Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.

EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.

Femoral nerve block (FNB) with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 just prior to wound closure.

Bupivacaine FNB: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.

EXPAREL Infiltration: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline admixed with bupivacaine HCl 0.5% with epinephrine 1:200,000 infiltrated into the surgical site just prior to wound closure.

All-Cause Mortality
Bupivacaine FNB + EXPAREL Infiltration Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/7 (0.00%)    
Hide Serious Adverse Events
Bupivacaine FNB + EXPAREL Infiltration Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bupivacaine FNB + EXPAREL Infiltration Bupivacaine FNB + EXPAREL Infiltration Admixed With Bupivacaine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      0/7 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Dyspnoea *  1/16 (6.25%)  1 0/7 (0.00%) 
Hypercapnia *  1/16 (6.25%)  1 0/7 (0.00%) 
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: James B. Jones, MD, PharmD
Organization: Pacira Pharmaceuticals Inc.
Phone: (973) 254-3560
EMail: jim.jones@pacira.com
Layout table for additonal information
Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02255500    
Other Study ID Numbers: 402-C-406
First Submitted: September 23, 2014
First Posted: October 2, 2014
Results First Submitted: May 20, 2016
Results First Posted: November 24, 2020
Last Update Posted: November 24, 2020