Local Anesthetic for Plateau Fractures

Phase 4

Not yet recruiting

• Conditions: Tibial Plateau Fractures
• Interventions: Drug: Bupivacaine injection; Other: Saline

• Registration Number: NCT06474949
• Lead Sponsor: University of Washington

Brief Summary

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

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2024-03-29
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-26
• Last Update Posted: 2024-06-26
• Study Start: 2024-08-01
• Primary Completion: 2026-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion:

• allergy to bupivacaine
• Prolonged external fixator use

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Bupivacaine injection	Bupivacaine
Saline	Saline	Saline

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Length of stay for hospitalization	From date of hospitalization up to one month post surgery	Length of stay for hospitalization