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NCT03020563 Clinical Trial

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

Clavicle Fracture Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03020563
Other study ID # 1611M99381
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date August 23, 2017
Est. completion date January 1, 2018

Study information
Verified date October 2018
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Liposomal Bupivacaine
Liposomal Bupivacaine
• Bupivacaine
Bupivacaine

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Analogue Pain Scale Averages between the two treatments Scale is based on 1-10 with 1 being the lowest pain and 10 being the highest pain. 72 hours post surgery
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