Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures

Last updated: February 25, 2025
Sponsor: University of Puerto Rico
Overall Status: Completed

Phase

4

Condition

N/A

Treatment

Intravenous ketorolac and oral acetaminophen

Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture

Intravenous morphine and oral oxycodone

Clinical Study ID

NCT04761302
A9290220
  • Ages 18-110
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures treated with intramedullary nailing. This study will explore an alternative for opioid medications for patients undergoing intramedullary nailing of tibial and femoral shaft fractures.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with tibial and femoral shaft fractures

  2. Patients undergoing intramedullary nailing

  3. Willing to participate in the protocol

Exclusion

Exclusion Criteria:

  1. Chronic pain disorder (daily use of oral opioids)

  2. Allergy or hypersensitivity to non steroid anti-inflammatory drug

  3. Impaired renal, cardiac, or hepatic function

  4. History of gastrointestinal bleeding or substance abuse

Study Design

Total Participants: 167
Treatment Group(s): 3
Primary Treatment: Intravenous ketorolac and oral acetaminophen
Phase: 4
Study Start date:
April 18, 2021
Estimated Completion Date:
October 01, 2022

Study Description

The data analysis for the study will be performed separately for patients with femoral fractures and for patients with tibial fractures. Therefore, the data analysis will compare patients with femoral fractures receiving the experimental treatment to patients with femoral fractures receiving the control treatment (Group 1 vs. Group 2). Likewise, patients with tibial fractures receiving the experimental treatment will be compared to patients with tibial fractures receiving the control treatment (Group 3 vs. Group 4).

Connect with a study center

  • University District Hospital

    San Juan, 00936
    Puerto Rico

    Site Not Available

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