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

Phase 4

Withdrawn

• Conditions: Arthroplasty, Replacement, Knee; Osteoarthritis, Knee
• Interventions: Drug: Bupivacaine 0.5 % with Epinephrine; Drug: Liposomal bupivacaine, 266mg; Drug: Ketorolac 30mg; Drug: Morphine 10mg; Drug: Bupivacaine 0.25% with Epinephrine

• Registration Number: NCT02765815
• Lead Sponsor: Holy Cross Hospital, Florida

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.

Study Timeline

• Study First Submitted: 2016-01-27
• Study Start: 2016-02
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-09
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 18 to 88 years of age.
2. Subject is scheduled to undergo primary unilateral Total Knee Arthroplasty.
3. Subject willing and able to sign the informed consent.
4. Subject is fluent in verbal and written English.
5. Subject agrees to take Liposomal bupivacaine or standard of care equivalent.

Exclusion Criteria

1. Previous Partial or Total Knee Arthroplasty of the study knee. Previous Non-Implant surgery on the study knee and contralateral knee is permitted.
2. Subject is pregnant or planning to become pregnant while enrolled in the study.
3. Subject has a history of narcotic or alcohol abuse.
4. 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).
5. 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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-drug cocktail alone	Bupivacaine 0.5 % with Epinephrine	Bupivacaine 0.5% with Epinephrine, Ketorolac 30mg, Morphine 10mg.
Multi-drug cocktail alone	Ketorolac 30mg	Bupivacaine 0.5% with Epinephrine, Ketorolac 30mg, Morphine 10mg.
Multi-drug cocktail alone	Morphine 10mg	Bupivacaine 0.5% with Epinephrine, Ketorolac 30mg, Morphine 10mg.
Exparel plus multi-drug cocktail	Morphine 10mg	Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg.
Exparel plus multi-drug cocktail	Bupivacaine 0.25% with Epinephrine	Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg.
Exparel plus multi-drug cocktail	Liposomal bupivacaine, 266mg	Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg.
Exparel plus multi-drug cocktail	Ketorolac 30mg	Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg.

Primary Outcome Measures

Name	Time	Method
Patient reported Visual Analog Scale (VAS) pain intensity score. Post-surgery hours 4-24.	VAS pain intensity scores will be collected starting four hours after end of surgery and every 4 hours thereafter until hour 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.	VAS pain intensity scores will be collected starting 24 hours after end of surgery and every 4 hours thereafter until hour 48, or discharge.	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.	VAS pain intensity scores will be collected starting 48 hours after end of surgery and every 4 hours thereafter until hour 72, or discharge.	The AUC of the VAS scores from 48-72 hours or until discharge will be compared between the two treatment groups.

Secondary Outcome Measures

Name	Time	Method
Cost:benefit analysis	TKA hospitalization charges, and VAS pain intensity scores pre-operative on day of surgery, 2-week and 6-week followup visits.	Correlation between hospital charges and improvement in VAS pain intensity score from baseline to the 2-week and 6-week follow-up time points.

Trial Locations

Locations (1)

Holy Cross Hospital Orthopedic Research Institute; 🇺🇸 Fort Lauderdale, Florida, United States