Does Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?

NCT ID: NCT03020563

Last Updated: 2018-10-16

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WITHDRAWN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

2017-08-23

Study Completion Date

2018-01-01

Brief Summary

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To determine whether liposomal bupivacaine wound infiltration decreases pain scores and narcotic use when compared to bupivacaine alone after open reduction internal fixation of midshaft clavicle fractures.

Detailed Description

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Conditions

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Clavicle Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liposomal Bupivacaine

Time release Bupivacaine

Group Type ACTIVE_COMPARATOR

Liposomal Bupivacaine

Intervention Type DRUG

Liposomal Bupivacaine

Bupivacaine

Immediate Acting Bupivacaine

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

Bupivacaine

Interventions

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Liposomal Bupivacaine

Liposomal Bupivacaine

Intervention Type DRUG

Bupivacaine

Bupivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mid-shaft Clavicle Fracture treated with ORIF

Exclusion Criteria

* Unable to be contacted for 72 hours post surgery
* Other concurrent surgical procedures
* Chronic narcotic user
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1611M99381

Identifier Type: -

Identifier Source: org_study_id

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