NCT06474949

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
16mo left

Started Aug 2024

Typical duration for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Aug 2024Aug 2027

First Submitted

Initial submission to the registry

March 29, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

March 29, 2024

Last Update Submit

June 19, 2024

Conditions

Tibial Plateau Fractures

Keywords

tibial plateau fracture

Outcome Measures

Primary Outcomes (1)

  • Pain in the knee visual analogue scale 11 point scale 0(no pain) -10 (worst pain)

    Pain at time of visit

    From date of hospitalization to end of follow-up at 6 months

Secondary Outcomes (1)

  • Length of stay for hospitalization

    From date of hospitalization up to one month post surgery

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

Bupivacaine

Drug: Bupivacaine injection

Saline

PLACEBO COMPARATOR

Saline

Other: Saline

Interventions

Bupivacaine injectionDRUG

Injection at end of Open Reduction Internal Fixation

Bupivacaine
SalineOTHER

Injection at end of Open Reduction Internal Fixation

Also known as: Placebo
Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • allergy to bupivacaine
  • Prolonged external fixator use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tibial Plateau Fractures

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesTibial FracturesKnee InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jonah Hebert-Davies

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Agel

CONTACT

206.744.4113bagel@uw.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patient is asleep at time of injection
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, School of Medicine: Orthopedics

Study Record Dates

First Submitted

March 29, 2024

First Posted

June 26, 2024

Study Start

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

June 26, 2024

Record last verified: 2024-06