Local Anesthetic for Plateau Fractures | NCT06474949

Studies
Local Anesthetic for Plateau Fractures

NCT06474949

Sponsor

University of Washington

Status

Not yet recruiting

Last Update Posted

Jun 26, 2024Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Tibial Plateau Fractures

Interventions

Bupivacaine injection
Saline

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Estimated

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 1, 2027Estimated

First Submitted Date

Mar 29, 2024

First Submission Date that Met QC Criteria

Jun 19, 2024

First Posted Date

Jun 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2024

Last Update Posted Date

Jun 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jonah Hebert-Davies, Assistant Professor, School of Medicine: Orthopedics, University of WashingtonPrincipal Investigator

Lead Sponsor

University of WashingtonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bupivacaine	Active Comparator	Bupivacaine	Drug: Bupivacaine injection
Saline	Placebo Comparator	Saline	Other: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine injection	Drug	Injection at end of Open Reduction Internal Fixation	Bupivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion:

allergy to bupivacaine
Prolonged external fixator use

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Julie Agel	Contact	206.744.4113		bagel@uw.edu

Overall Officials

Name	Affiliation	Role
Jonah Hebert-Davies	University of Washington	Principal Investigator

Locations

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 3, 2024	Jun 5, 2024	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000092463	Tibial Plateau Fractures

Ancestor Terms

ID	Term
D000092443	Knee Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D013978	Tibial Fractures

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided