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A Comparison of Exparel Local Anesthetic in Total Knee Arthroplasty (TKA) Patients

Primary Purpose

Osteoarthritis, Knee, Arthroplasty, Replacement, Knee

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Liposomal bupivacaine, 266mg

Bupivacaine 0.5 % with Epinephrine

Ketorolac 30mg

Morphine 10mg

Bupivacaine 0.25% with Epinephrine

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring TKA, Knee replacement, Arthritis, Knee

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 to 88 years of age.
Subject is scheduled to undergo primary unilateral Total Knee Arthroplasty.
Subject willing and able to sign the informed consent.
Subject is fluent in verbal and written English.
Subject agrees to take Liposomal bupivacaine or standard of care equivalent.

Exclusion Criteria:

Previous Partial or Total Knee Arthroplasty of the study knee. Previous Non-Implant surgery on the study knee and contralateral knee is permitted.
Subject is pregnant or planning to become pregnant while enrolled in the study.
Subject has a history of narcotic or alcohol abuse.
Subjects with hepatic disease or renal impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x upper limit of normal or estimated glomerular filtration rate (eGFR) < 30 ml/min within 30 days of surgery).
For any reason, in the opinion of the investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, etc.)

Sites / Locations

Holy Cross Hospital Orthopedic Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Exparel plus multi-drug cocktail

Multi-drug cocktail alone

Arm Description

Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg.

Bupivacaine 0.5% with Epinephrine, Ketorolac 30mg, Morphine 10mg.

Outcomes

Primary Outcome Measures

Patient reported Visual Analog Scale (VAS) pain intensity score. Post-surgery hours 4-24.

The area under the curve (AUC) of the VAS scores from 4-24 hours will be compared between the two treatment groups.

Patient reported VAS pain intensity score. Post-surgery hours 24-48.

The AUC of the VAS scores from 24-48 hours or until discharge will be compared between the two treatment groups.

Patient reported VAS pain intensity score. Post-surgery hours 48-72.

The AUC of the VAS scores from 48-72 hours or until discharge will be compared between the two treatment groups.

Secondary Outcome Measures

Cost:benefit analysis

Correlation between hospital charges and improvement in VAS pain intensity score from baseline to the 2-week and 6-week follow-up time points.

Full Information

NCT ID

NCT02765815

First Posted

January 27, 2016

Last Updated

August 8, 2017

Sponsor

Holy Cross Hospital, Florida

1. Study Identification

Unique Protocol Identification Number

NCT02765815

Brief Title

A Comparison of Exparel Local Anesthetic in Total Knee Arthroplasty (TKA) Patients

Official Title

A Prospective Randomized Case Series Comparison on the Clinical Efficacy of Exparel Local Anesthetic in Total Knee Arthroplasty Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Withdrawn

Why Stopped

competing protocol

Study Start Date

February 2016 (Anticipated)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Holy Cross Hospital, Florida

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period of TKA patients who receive Exparel compared with the surgeon's standard method (detailed below) for pain management intraoperatively.

Detailed Description

This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period. Subjects scheduled for a planned total knee arthroplasty procedure will be consented and those meeting study criteria will be randomized to receive intra-operative injections at the surgical site of liposomal bupivicaine plus a multi-drug cocktail, or a multi-drug cocktail alone. This study will recruit subjects on an ongoing basis with a minimum of 130 study participants and a maximum of 156. Efficacy data on surgical pain control and safety data will be collected at frequent intervals during the hospitalization. Each study participant will be followed for a minimum 6 week follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee, Arthroplasty, Replacement, Knee

Keywords

TKA, Knee replacement, Arthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exparel plus multi-drug cocktail

Arm Type

Active Comparator

Arm Description

Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg.

Arm Title

Multi-drug cocktail alone

Arm Type

Active Comparator

Arm Description

Bupivacaine 0.5% with Epinephrine, Ketorolac 30mg, Morphine 10mg.

Intervention Type

Drug

Intervention Name(s)

Liposomal bupivacaine, 266mg

Other Intervention Name(s)

Exparel Injection

Intervention Type

Drug

Intervention Name(s)

Bupivacaine 0.5 % with Epinephrine

Intervention Type

Drug

Intervention Name(s)

Ketorolac 30mg

Intervention Type

Drug

Intervention Name(s)

Morphine 10mg

Intervention Type

Drug

Intervention Name(s)

Bupivacaine 0.25% with Epinephrine

Primary Outcome Measure Information:

Title

Patient reported Visual Analog Scale (VAS) pain intensity score. Post-surgery hours 4-24.

Description

The area under the curve (AUC) of the VAS scores from 4-24 hours will be compared between the two treatment groups.

Time Frame

VAS pain intensity scores will be collected starting four hours after end of surgery and every 4 hours thereafter until hour 24.

Title

Patient reported VAS pain intensity score. Post-surgery hours 24-48.

Description

The AUC of the VAS scores from 24-48 hours or until discharge will be compared between the two treatment groups.

Time Frame

VAS pain intensity scores will be collected starting 24 hours after end of surgery and every 4 hours thereafter until hour 48, or discharge.

Title

Patient reported VAS pain intensity score. Post-surgery hours 48-72.

Description

The AUC of the VAS scores from 48-72 hours or until discharge will be compared between the two treatment groups.

Time Frame

VAS pain intensity scores will be collected starting 48 hours after end of surgery and every 4 hours thereafter until hour 72, or discharge.

Secondary Outcome Measure Information:

Title

Cost:benefit analysis

Description

Correlation between hospital charges and improvement in VAS pain intensity score from baseline to the 2-week and 6-week follow-up time points.

Time Frame

TKA hospitalization charges, and VAS pain intensity scores pre-operative on day of surgery, 2-week and 6-week followup visits.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

88 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 to 88 years of age. Subject is scheduled to undergo primary unilateral Total Knee Arthroplasty. Subject willing and able to sign the informed consent. Subject is fluent in verbal and written English. Subject agrees to take Liposomal bupivacaine or standard of care equivalent. Exclusion Criteria: Previous Partial or Total Knee Arthroplasty of the study knee. Previous Non-Implant surgery on the study knee and contralateral knee is permitted. Subject is pregnant or planning to become pregnant while enrolled in the study. Subject has a history of narcotic or alcohol abuse. Subjects with hepatic disease or renal impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x upper limit of normal or estimated glomerular filtration rate (eGFR) < 30 ml/min within 30 days of surgery). For any reason, in the opinion of the investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, etc.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Roche, MD

Organizational Affiliation

Holy Cross Orthopedic Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Holy Cross Hospital Orthopedic Research Institute

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33334

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17403800

Citation

Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

Results Reference

result

PubMed Identifier

10422923

Citation

Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.

Results Reference

result

PubMed Identifier

21294923

Citation

Fetherston CM, Ward S. Relationships between post operative pain management and short term functional mobility in total knee arthroplasty patients with a femoral nerve catheter: a preliminary study. J Orthop Surg Res. 2011 Feb 7;6:7. doi: 10.1186/1749-799X-6-7.

Results Reference

result

PubMed Identifier

22227789

Citation

American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.

Results Reference

result

PubMed Identifier

24793570

Citation

Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4.

Results Reference

result

PubMed Identifier

24938586

Citation

Broome CB, Burnikel B. Novel strategies to improve early outcomes following total knee arthroplasty: a case control study of intra articular injection versus femoral nerve block. Int Orthop. 2014 Oct;38(10):2087-9. doi: 10.1007/s00264-014-2392-0. Epub 2014 Jun 18.

Results Reference

result

PubMed Identifier

22285545

Citation

Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.

Results Reference

result

Learn more about this trial

A Comparison of Exparel Local Anesthetic in Total Knee Arthroplasty (TKA) Patients

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