Clinical trial NCT02765815: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Arthroplasty, Replacement, Knee
Keywords: TKA
Knee replacement
Arthritis
Knee
Lead sponsor: Holy Cross Hospital, Florida
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Patient reported Visual Analog Scale (VAS) pain intensity score. Post-surgery hours 4-24.
timeFrame: VAS pain intensity scores will be collected starting four hours after end of surgery and every 4 hours thereafter until hour 24.
measure: Patient reported VAS pain intensity score. Post-surgery hours 24-48.
timeFrame: VAS pain intensity scores will be collected starting 24 hours after end of surgery and every 4 hours thereafter until hour 48, or discharge.
measure: Patient reported VAS pain intensity score. Post-surgery hours 48-72.
timeFrame: 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 outcomes:
measure: Cost:benefit analysis
timeFrame: TKA hospitalization charges, and VAS pain intensity scores pre-operative on day of surgery, 2-week and 6-week followup visits.
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital Orthopedic Research Institute
state: Florida
Study officials:
affiliation: Holy Cross Orthopedic Research Institute
name: Martin Roche, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.