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Comparing Post-Op Narcotic Usage in Patients Receiving Periarticular Exparel vs. Standard Periarticular Joint Inj

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ClinicalTrials.gov Identifier: NCT02682498
Recruitment Status : Completed
First Posted : February 15, 2016
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph Brian Rinehart, University of California, Irvine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Investigator);   Primary Purpose: Treatment
Condition Arthroplasty, Replacement, Knee
Interventions Drug: (Bupivacaine Liposome Injectable Suspension)
Drug: Standard Preparation
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EXPAREL® Bupivacaine Liposome Suspension Standard Periarticular Joint Injection
Hide Arm/Group Description

Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.

(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.

A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
Period Title: Overall Study
Started 18 20
Completed 18 20
Not Completed 0 0
Arm/Group Title EXPAREL® Bupivacaine Liposome Suspension Standard Periarticular Joint Injection Total
Hide Arm/Group Description

Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.

(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.

A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery. Total of all reporting groups
Overall Number of Baseline Participants 20 18 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 18 participants 38 participants
64.14  (10.18) 60  (12.83) 60  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
Female
9
  45.0%
12
  66.7%
21
  55.3%
Male
11
  55.0%
6
  33.3%
17
  44.7%
1.Primary Outcome
Title 48 Hour Post-surgical Opioid Use
Hide Description A comparison of group means between the control group and study group with regards to 48 hour opioid use.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EXPAREL® Bupivacaine Liposome Suspension Standard Periarticular Joint Injection
Hide Arm/Group Description:

Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.

(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.

A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
Overall Number of Participants Analyzed 20 18
Mean (Standard Deviation)
Unit of Measure: morphine equivalents
5.32  (1.72) 5.07  (2.05)
2.Secondary Outcome
Title Recovery Room Opioid Use
Hide Description Post anesthesia care unit (recovery room) opioid use in total mg morphine IV equivalent in comparison of standard knee injection post-operatively.
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.
Arm/Group Title EXPAREL® Bupivacaine Liposome Suspension Standard Periarticular Joint Injection
Hide Arm/Group Description:

Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.

(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.

A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
Overall Number of Participants Analyzed 20 18
Median (Inter-Quartile Range)
Unit of Measure: Total morphine equivalents
5
(0 to 10)
5
(5 to 20)
3.Secondary Outcome
Title Average Daily Opioid Use During Admission
Hide Description Opioid use will be monitored daily from the time of admission in comparison of standard knee injection post-operatively.
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.
Arm/Group Title EXPAREL® Bupivacaine Liposome Suspension Standard Periarticular Joint Injection
Hide Arm/Group Description:

Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.

(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.

A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
Overall Number of Participants Analyzed 20 18
Mean (Inter-Quartile Range)
Unit of Measure: Total Morphine Equivalents
100
(0 to 150)
103
(0 to 275)
4.Secondary Outcome
Title Average Daily Patient Pain Score
Hide Description Examining the average daily patient pain score in comparison of standard knee injection post-operatively. The measure is the Visual-Analog-Scale (VAS) for subjective pain reporting. The minimum 0 (no pain) and the maximum is 10 (worst pain imagineable). There is only one measure in the scale (i.e. there are no subscales). Lower scores on the VAS scale equate to less pain and are therefore desirable.
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.
Arm/Group Title EXPAREL® Bupivacaine Liposome Suspension Standard Periarticular Joint Injection
Hide Arm/Group Description:

Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.

(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.

A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.
Overall Number of Participants Analyzed 20 18
Mean (Inter-Quartile Range)
Unit of Measure: Visual Analog Scale Rating
4.75
(0 to 9.5)
5.75
(0 to 9)
5.Secondary Outcome
Title Post-operative Complications
Hide Description Examining the post-operative complication in comparison of standard knee injection post-operatively.
Time Frame Up to 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.
Arm/Group Title EXPAREL® Bupivacaine Liposome Suspension Standard Periarticular Joint Injection
Hide Arm/Group Description:

Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.

(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.

A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
Overall Number of Participants Analyzed 18 20
Measure Type: Number
Unit of Measure: complications
0 0
Time Frame 10/24/13-8/18/15
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EXPAREL® Bupivacaine Liposome Suspension Standard Periarticular Joint Injection
Hide Arm/Group Description

Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.

(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.

A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
All-Cause Mortality
EXPAREL® Bupivacaine Liposome Suspension Standard Periarticular Joint Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
EXPAREL® Bupivacaine Liposome Suspension Standard Periarticular Joint Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EXPAREL® Bupivacaine Liposome Suspension Standard Periarticular Joint Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/20 (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
Layout table for Results Point of Contact information
Name/Title: Joseph Rinehart
Organization: UC Irvine Health
Phone: 714-456-5059
EMail: jrinehar@uci.edu
Publications:
Layout table for additonal information
Responsible Party: Joseph Brian Rinehart, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02682498    
Other Study ID Numbers: UCIANES08
First Submitted: February 3, 2016
First Posted: February 15, 2016
Results First Submitted: October 31, 2016
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017