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Completed

NCT Number: NCT04761302

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

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.

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Key information

Conditions

Femur Fracture Femoral Fractures Fractures, Bone Leg Injuries Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Tibial Fractures Wounds and Injuries

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University District Hospital

San Juan, 00936, Puerto Rico

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with tibial and femoral shaft fractures
  • Patients undergoing intramedullary nailing
  • Willing to participate in the protocol

Exclusion criteria

  • Chronic pain disorder (daily use of oral opioids)
  • Allergy or hypersensitivity to non steroid anti-inflammatory drug
  • Impaired renal, cardiac, or hepatic function
  • History of gastrointestinal bleeding or substance abuse

Treatment and study plan

Intravenous ketorolac and oral acetaminophen

Drug

ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group

Intravenous morphine and oral oxycodone

Drug

Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.

Primary outcomes

  1. 12hrs VAS Pain Scores

    Time frame: Measured at postoperative hour 12

    Visual Analog Scale; 0-10 (10 indicates highest degree of pain)

  2. 24hrs VAS Pain Score

    Time frame: Measured at postoperative hour 24

    Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain)

  3. 36hrs VAS Pain Scores

    Time frame: Measured at postoperative hour 36

    Visual Analog Scale; 0-10 (10 indicates highest degree of pain)

  4. 48hrs VAS Pain Scores

    Time frame: Measured at postoperative hour 48

    Visual Analog Scale; 0-10 (10 indicates highest degree of pain)

  5. 12hrs MME

    Time frame: Measured at postoperative hour 12

    Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME)

  6. 24hrs MME

    Time frame: Measured at postoperative hour 24

    Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME)

  7. 36hrs MME

    Time frame: Measured at postoperative hour 36

    Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME)

  8. 48hrs MME

    Time frame: Measured at postoperative hour 48

    Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME)

Secondary outcomes

  1. Hospital Length of Stay

    Time frame: Determined by discharge date

    Time from intervention to discharge

Sponsors and collaborators

Lead sponsor

University of Puerto Rico

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2021
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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