Liposomal Bupivacaine in Total Knee Arthroplasty

NCT ID: NCT02426164

Last Updated: 2016-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Pain, Postoperative Arthroplasty, Replacement, Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Liposomal bupivacaine

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

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

bupivacaine HCl, morphine, epinephrine, methylprednisolone

Intervention Type DRUG

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

Interventions

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Liposomal bupivacaine

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

Intervention Type DRUG

bupivacaine HCl, morphine, epinephrine, methylprednisolone

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

Intervention Type DRUG

Other Intervention Names

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Exparel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Creighton University Medical Center

OTHER

Sponsor Role collaborator

CHI Health Mercy Hospital

OTHER

Sponsor Role collaborator

Miller Orthopedic Specialists

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clifford K Boese, MD

Role: PRINCIPAL_INVESTIGATOR

Miller Orthopedic Specialists

Locations

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Miller Orthopedic Specialists

Council Bluffs, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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633913

Identifier Type: -

Identifier Source: org_study_id

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