Local Anesthetic for Plateau Fractures

June 19, 2024 updated by: Jonah Hebert-Davies, University of Washington
Subjects may receive an injection at the end of the surgery to fix their broken leg that may reduce their pain and hospital stay

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Julie Agel
  • Phone Number: 206.744.4113
  • Email: bagel@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion:

  • allergy to bupivacaine
  • Prolonged external fixator use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Other: Saline
Injection at end of Open Reduction Internal Fixation
Other Names:
  • Placebo
Active Comparator: Bupivacaine
Drug: Bupivacaine injection
Injection at end of Open Reduction Internal Fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain in the knee visual analogue scale 11 point scale 0(no pain) -10 (worst pain)
Time Frame: From date of hospitalization to end of follow-up at 6 months
Pain at time of visit
From date of hospitalization to end of follow-up at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay for hospitalization
Time Frame: From date of hospitalization up to one month post surgery
Length of stay for hospitalization
From date of hospitalization up to one month post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Jonah Hebert-Davies, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

March 29, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00017105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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