Liposomal Bupivacaine in Total Knee Arthroplasty

Condition(s) targeted: Pain, Postoperative; Arthroplasty, Replacement, Knee; Osteoarthritis

Intervention: Liposomal bupivacaine (Drug); bupivacaine HCl, morphine, epinephrine, methylprednisolone (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Miller Orthopedic Specialists

Official(s) and/or principal investigator(s):
Clifford K Boese, MD, Principal Investigator, Affiliation: Miller Orthopedic Specialists

Overall contact:
Leslie Centeno, Phone: 712-388-0144, Email: Lcenteno@millerortho.com

Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.

Official title: Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Mean visual analog scale (VAS) pain scores

Mean visual analog scale (VAS) pain scores

Mean visual analog scale (VAS) pain scores

Pain assessment phone call

Secondary outcome: Complications

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients undergoing a primary unilateral total knee arthroplasty by the PI of the

trial Exclusion Criteria:

- Patients with a sensitivity to marcaine

- Pregnant or lactating women

- Non-English speaking individuals

Leslie Centeno, Phone: 712-388-0144, Email: Lcenteno@millerortho.com

Miller Orthopedic Specialists, Council Bluffs, Iowa 51503, United States

Starting date: June 2015
Last updated: April 21, 2015