NSAIDS vs Opioids in Tibial Fractures | NCT05332314

Studies
NSAIDS vs Opioids in Tibial Fractures

NCT05332314

Sponsor

University of Louisville

Status

Unknown status

Last Update Posted

Apr 18, 2022Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Trauma

Interventions

NSAIDs

Countries

United States

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 12, 2019Actual

Primary Completion Date

Jan 30, 2024Estimated

Completion Date

May 30, 2025Estimated

First Submitted Date

Apr 8, 2022

First Submission Date that Met QC Criteria

Apr 15, 2022

First Posted Date

Apr 18, 2022Actual

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

Apr 15, 2022

Last Update Posted Date

Apr 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rodolfo Zamora, MD, Associate Professor, University of LouisvillePrincipal Investigator

Lead Sponsor

University of LouisvilleOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will attempt to determine if there is a statistic difference between the time to union, non-union rate and post-operative pain of patients who receive opioids for pain control vs. patients who receive NSAIDs and a reduced dosage of opioids for pain management

Detailed Description

The study will be a prospective interventional study with two randomized parallel groups.

Randomization will take place immediately following the identification of a potential participant. The control group will receive the standard of care for diaphyseal tibia fractures. The standard of care consists of intramedullary nailing and post-operative opioids for pain control. The interventional group will have the same surgical indication and intervention but will differ in the primary method of pain control. The study group will receive NSAIDs and a reduced dosage of opioids for pain control. Primary outcome measures will be time to union, non-union, and pain over the post-operative period measured by a VAS pain scale. Once the data collection of both groups is complete, the statistical analysis will begin to determine if there is a statistical difference between the control and study groups in the primary outcome measurements.

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
NSAIDs	Experimental	This arm is given NSAIDs perioperatively and after discharge	Drug: NSAIDs
Opioids	No Intervention	This arm will be given the standard opioids treatment to control pain perioperatively and at discharge.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NSAIDs	Drug	The patients will be given NSAIDs with a reduced dose of the standard opioids treatment.	NSAIDs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to union	The time from surgery to bone healing	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients between the ages of 18 and 105
Diaphyseal tibia fracture (OTA/AO 42 A, B)

Exclusion Criteria:

-Tibial fractures not treated with intramedullary nails

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

105 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rodolfo Zamora	Contact	5028528834		rodolfo.zamora@louisville.edu
Salwa Rashid	Contact	5028526964		salwa.rashid@louisville.edu

Overall Officials

Name	Affiliation	Role
Rodolfo Zamora, MD	University of Louisville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Louisville Hospital	Recruiting	Louisville	Kentucky	40202	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26584270	Background	Giannoudis PV, Hak D, Sanders D, Donohoe E, Tosounidis T, Bahney C. Inflammation, Bone Healing, and Anti-Inflammatory Drugs: An Update. J Orthop Trauma. 2015 Dec;29 Suppl 12:S6-9. doi: 10.1097/BOT.0000000000000465.
22622792	Background	Lu C, Xing Z, Wang X, Mao J, Marcucio RS, Miclau T. Anti-inflammatory treatment increases angiogenesis during early fracture healing. Arch Orthop Trauma Surg. 2012 Aug;132(8):1205-13. doi: 10.1007/s00402-012-1525-4. Epub 2012 May 24.

ID	Term
D000894	Anti-Inflammatory Agents, Non-Steroidal
D007052	Ibuprofen

ID	Term
D018712	Analgesics, Non-Narcotic
D000700	Analgesics
D018689	Sensory System Agents
D018373	Peripheral Nervous System Agents