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

NCT02765815 | Withdrawn Phase 4

• 1 other identifier: Exparel TKA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Arthroplasty, Replacement, Knee

Keywords

TKA; Knee replacement; Arthritis; Knee

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (1)

• Cost:benefit analysis

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

Study Arms (2)

Exparel plus multi-drug cocktail

ACTIVE COMPARATOR

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

Drug: Liposomal bupivacaine, 266mg; Drug: Ketorolac 30mg; Drug: Morphine 10mg; Drug: Bupivacaine 0.25% with Epinephrine

Multi-drug cocktail alone

ACTIVE COMPARATOR

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

Drug: Bupivacaine 0.5 % with Epinephrine; Drug: Ketorolac 30mg; Drug: Morphine 10mg

Interventions

Liposomal bupivacaine, 266mg DRUG

Also known as: Exparel Injection

Exparel plus multi-drug cocktail

Bupivacaine 0.5 % with Epinephrine DRUG

Multi-drug cocktail alone

Ketorolac 30mg DRUG

Exparel plus multi-drug cocktail; Multi-drug cocktail alone

Morphine 10mg DRUG

Exparel plus multi-drug cocktail; Multi-drug cocktail alone

Bupivacaine 0.25% with Epinephrine DRUG

Exparel plus multi-drug cocktail

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Holy Cross Hospital, Florida: lead

Study Sites (1)

Holy Cross Hospital Orthopedic Research Institute

Fort Lauderdale, Florida, 33334, United States

Location

Related Publications (7)

• 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.

  PMID: 17403800 RESULT

• 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.

  PMID: 10422923 RESULT

• 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.

  PMID: 21294923 RESULT

• 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.

  PMID: 22227789 RESULT

• 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.

  PMID: 24793570 RESULT

• 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.

  PMID: 24938586 RESULT

• 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.

  PMID: 22285545 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis

Interventions

Bupivacaine; Epinephrine; Ketorolac; Morphine

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Martin Roche, MD

  Holy Cross Orthopedic Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: May 9, 2016
• Study Start: February 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)