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

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status and phase

Withdrawn
Phase 4

Conditions

Clavicle Fracture

Treatments

Drug: Liposomal Bupivacaine
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03020563
1611M99381

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups, including a placebo group

Liposomal Bupivacaine
Active Comparator group
Description:
Time release Bupivacaine
Treatment:
Drug: Liposomal Bupivacaine
Bupivacaine
Placebo Comparator group
Description:
Immediate Acting Bupivacaine
Treatment:
Drug: Bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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