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NCT05332314 Clinical Trial

NSAIDS vs Opioids in Tibial Fractures

Trauma Clinical Trial

Official title:
NSAIDs and Time to Union in Diaphyseal Tibia Fractures: Do NSAIDs Make a Difference

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05332314
Other study ID # 19.0676
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 12, 2019
Est. completion date May 30, 2025

Study information
Verified date April 2022
Source University of Louisville
Contact Rodolfo Zamora
Phone 5028528834
Email rodolfo.zamora@louisville.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date May 30, 2025
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 105 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States University of Louisville Louisville Kentucky
United States University of Louisville Hospital Louisville Kentucky

Sponsors (1)
Lead Sponsor Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Marquez-Lara A, Hutchinson ID, Nuñez 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). pii: e4. doi: 10.2106/JBJS.RVW.O.00055. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time to union The time from surgery to bone healing through study completion, an average of 1 year
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