NSAIDS vs Opioids in Tibial Fractures

NCT05332314 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 19.0676
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

• Time to union

  The time from surgery to bone healing

  through study completion, an average of 1 year

Study Arms (2)

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

NSAIDs DRUG

The patients will be given NSAIDs with a reduced dose of the standard opioids treatment.

Also known as: Ibuprofen

NSAIDs

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Tibial fractures not treated with intramedullary nails

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (2)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40292, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 26584270 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.

  PMID: 22622792 BACKGROUND

• Sathyendra V, Darowish M. Basic science of bone healing. Hand Clin. 2013 Nov;29(4):473-81. doi: 10.1016/j.hcl.2013.08.002. Epub 2013 Oct 15.

  PMID: 24209946 BACKGROUND

• Schindeler A, McDonald MM, Bokko P, Little DG. Bone remodeling during fracture repair: The cellular picture. Semin Cell Dev Biol. 2008 Oct;19(5):459-66. doi: 10.1016/j.semcdb.2008.07.004. Epub 2008 Jul 25.

  PMID: 18692584 BACKGROUND

• Geusens P, Emans PJ, de Jong JJ, van den Bergh J. NSAIDs and fracture healing. Curr Opin Rheumatol. 2013 Jul;25(4):524-31. doi: 10.1097/BOR.0b013e32836200b8.

  PMID: 23680778 BACKGROUND

• Marquez-Lara A, Hutchinson ID, Nunez F Jr, Smith TL, Miller AN. Nonsteroidal Anti-Inflammatory Drugs and Bone-Healing: A Systematic Review of Research Quality. JBJS Rev. 2016 Mar 15;4(3):e4. doi: 10.2106/JBJS.RVW.O.00055.

  PMID: 27500434 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Ibuprofen

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Rodolfo Zamora, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodolfo Zamora

CONTACT

5028528834; rodolfo.zamora@louisville.edu

Salwa Rashid

CONTACT

5028526964; salwa.rashid@louisville.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 18, 2022
• Study Start: November 12, 2019
• Primary Completion: January 30, 2024
• Study Completion: May 30, 2025
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)