Local Anesthetic for Plateau Fractures

NCT ID: NCT06474949

Last Updated: 2024-06-26

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

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2027-08-01

Brief Summary

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Subjects may receive an injection at the end of the surgery to fix their broken leg that may reduce their pain and hospital stay

Detailed Description

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Subjects will be randomized to bupivicaine or saline injection in the joint at the end of Open Reduction Internal Fixation of the tibial plateau fracture

Conditions

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Tibial Plateau Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Patient is asleep at time of injection

Study Groups

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Bupivacaine

Bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine injection

Intervention Type DRUG

Injection at end of Open Reduction Internal Fixation

Saline

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Injection at end of Open Reduction Internal Fixation

Interventions

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Bupivacaine injection

Injection at end of Open Reduction Internal Fixation

Intervention Type DRUG

Saline

Injection at end of Open Reduction Internal Fixation

Intervention Type OTHER

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* Age \>=18 year ,
* tibial plateau fracture undergoing Open Reduction and fixation"

Exclusion:

* allergy to bupivacaine
* Prolonged external fixator use
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Jonah Hebert-Davies

Assistant Professor, School of Medicine: Orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonah Hebert-Davies

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Central Contacts

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Julie Agel

Role: CONTACT

206.744.4113

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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STUDY00017105

Identifier Type: -

Identifier Source: org_study_id

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