Liposomal Bupivacaine in Total Knee Arthroplasty

Phase 4

Withdrawn

• Conditions: Pain, Postoperative; Arthroplasty, Replacement, Knee; Osteoarthritis
• Interventions: Drug: Liposomal bupivacaine; Drug: bupivacaine HCl, morphine, epinephrine, methylprednisolone

• Registration Number: NCT02426164
• Lead Sponsor: Miller Orthopedic Specialists

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-24
• Study Start: 2015-06
• Last Update Submitted: 2016-03-18
• Last Update Posted: 2016-03-22
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal bupivacaine	Liposomal bupivacaine	Periarticular infiltration of 20cc of liposomal bupivacaine with 20cc of normal saline administered prior to cementation of knee implants
bupivacaine HCl, morphine, epinephrine, methylprednisolone	bupivacaine HCl, morphine, epinephrine, methylprednisolone	Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants

Primary Outcome Measures

Name	Time	Method
Mean visual analog scale (VAS) pain scores	Post-operative day 2	Self-reported pain scores from 0=no pain to 10=severe pain
Pain assessment phone call	Post-operative day 3	Subjects will be called on post-operative day three by one of the investigators of the study. Subjects will be asked to rate their current pain level from 1 to 10 and to rate their worst pain level from 1 to 10 that day.

Secondary Outcome Measures

Name	Time	Method
Complications	Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days.	Number of patients with complications

Trial Locations

Locations (1)

Miller Orthopedic Specialists; 🇺🇸 Council Bluffs, Iowa, United States