Liposomal Bupivacaine in Total Knee Arthroplasty

Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02426164

Enrollment

Registered

2015-04-24

Start date

2015-06-30

Completion date

2017-06-30

Last updated

2016-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee, Osteoarthritis, Pain, Postoperative

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.

Interventions

DRUGLiposomal bupivacaine

Periarticular infiltration of the liposomal bupivacaine with 20cc of normal saline

DRUGbupivacaine HCl, morphine, epinephrine, methylprednisolone

Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Mean visual analog scale (VAS) pain scores	Night of surgery	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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026