Back to resultsDoes Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?
Primary Purpose
Clavicle Fracture
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal Bupivacaine
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Clavicle Fracture
Eligibility Criteria
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Liposomal Bupivacaine
Bupivacaine
Arm Description
Time release Bupivacaine
Immediate Acting Bupivacaine
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03020563
First Posted
January 5, 2017
Last Updated
October 11, 2018
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03020563
Brief Title
Does Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?
Official Title
Does Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
no longer necessary
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clavicle Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine
Arm Type
Active Comparator
Arm Description
Time release Bupivacaine
Arm Title
Bupivacaine
Arm Type
Placebo Comparator
Arm Description
Immediate Acting Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivacaine
Intervention Description
Liposomal Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Bupivacaine
Primary Outcome Measure Information:
Title
Visual Analogue Pain Scale Averages between the two treatments
Description
Scale is based on 1-10 with 1 being the lowest pain and 10 being the highest pain.
Time Frame
72 hours post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Does Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?
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