NSAIDS vs Opioids in Tibial Fractures

University of Louisville (UOFL)

Status and phase: Enrolling; Phase 4

Conditions: Trauma

Treatments: Drug: NSAIDs

Study type: Interventional

Funder types: Other

Identifiers

NCT05332314

19.0676

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 105 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

NSAIDs

Experimental group

Description:

This arm is given NSAIDs perioperatively and after discharge

Treatment:

Drug: NSAIDs

Opioids

No Intervention group

Description:

This arm will be given the standard opioids treatment to control pain perioperatively and at discharge.