Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty

• Status: Terminated
• Trial end date: 2018-07-16
• Target enrollment: 0
• Participant gender: All

Summary

Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on physical therapy measures and pain scores as well as opiate consumption.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

1. The subject is scheduled for elective unilateral TKA;

2. The subject is ≥ 18 years and ≤ 80 years;

3. The subject's weight is between 65-130 kg;

4. The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural);

5. The patient agrees to receive an adductor canal block;

6. American Society of Anesthesiologists class 1-3.

Exclusion Criteria:

1. Subject is < 18 years of age or >80 years of age;

2. Subject is non-English speaking;

3. Subject is known or believed to be pregnant;

4. Subject is a prisoner;

5. Subject has impaired decision-making capacity per discretion of the Investigator;

6. Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative aspiration;

7. Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate;

8. Significant pre-existing neuropathy on the operative limb;

9. Significant renal, cardiac or hepatic disease per discretion of the investigator;

10. American Society of Anesthesiologists class 4-5;

11. Known hypersensitivity and/or allergies to local anesthetics;

12. Chronic Opioid Use (daily or almost daily use of opioids for > 3 months).