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

Phase 4

Withdrawn

• Conditions: Clavicle Fracture
• Interventions: Drug: Liposomal Bupivacaine; Drug: Bupivacaine

• Registration Number: NCT03020563
• Lead Sponsor: University of Minnesota

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Study Start: 2017-08-23
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

• Mid-shaft Clavicle Fracture treated with ORIF

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Exclusion Criteria

• Unable to be contacted for 72 hours post surgery
• Other concurrent surgical procedures
• Chronic narcotic user

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine	Liposomal Bupivacaine	Time release Bupivacaine
Bupivacaine	Bupivacaine	Immediate Acting Bupivacaine

Primary Outcome Measures

Name	Time	Method
Visual Analogue Pain Scale Averages between the two treatments	72 hours post surgery	Scale is based on 1-10 with 1 being the lowest pain and 10 being the highest pain.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States