Liposomal Bupivacaine in Total Knee Arthroplasty

Miller Orthopedic Specialists

Status and phase: Withdrawn; Phase 4

Conditions: Arthroplasty, Replacement, Knee; Osteoarthritis; Pain, Postoperative

Treatments: Drug: Liposomal bupivacaine; Drug: bupivacaine HCl, morphine, epinephrine, methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT02426164

633913

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Liposomal bupivacaine

Active Comparator group

Description:

Periarticular infiltration of 20cc of liposomal bupivacaine with 20cc of normal saline administered prior to cementation of knee implants

Treatment:

Drug: Liposomal bupivacaine

bupivacaine HCl, morphine, epinephrine, methylprednisolone

Active Comparator group

Description:

Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants

Treatment:

Drug: bupivacaine HCl, morphine, epinephrine, methylprednisolone