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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02765815
• Other study ID #: Exparel TKA
• Status: Withdrawn
• Phase: Phase 4
• First received: January 27, 2016
• Last updated: August 8, 2017
• Start date: February 2016
• Est. completion date: January 2017

Study information

• Verified date: August 2017
• Source: Holy Cross Hospital, Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Liposomal bupivacaine, 266mg

• Bupivacaine 0.5 % with Epinephrine

• Ketorolac 30mg

• Morphine 10mg

• Bupivacaine 0.25% with Epinephrine

Locations

Country	Name	City	State
United States	Holy Cross Hospital Orthopedic Research Institute	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Holy Cross Hospital, Florida

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Anes — View 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. — View 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 arthroplas — View 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 201 — View 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. — View 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: 10.1186/1749-799 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	VAS pain intensity scores will be collected starting four hours after end of surgery and every 4 hours thereafter until hour 24.
Primary	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.	VAS pain intensity scores will be collected starting 24 hours after end of surgery and every 4 hours thereafter until hour 48, or discharge.
Primary	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.	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	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.	TKA hospitalization charges, and VAS pain intensity scores pre-operative on day of surgery, 2-week and 6-week followup visits.