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.

Study Overview

• Status: Completed
• Conditions: Tibial Fractures; Femur Fracture
• Intervention / Treatment: Drug: Intravenous ketorolac and oral acetaminophen; Drug: Intravenous morphine and oral oxycodone

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936
    • University District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients with tibial and femoral shaft fractures
2. Patients undergoing intramedullary nailing
3. Willing to participate in the protocol

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and oral acetaminophen; Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: 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. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.	Drug: Intravenous ketorolac and oral acetaminophen; 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
Active Comparator: Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and oral oxycodone; Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.	Drug: Intravenous morphine and oral oxycodone; Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.
Experimental: Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen; Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: 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. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.	Drug: Intravenous ketorolac and oral acetaminophen; 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
Active Comparator: Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and oral oxycodone; Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.	Drug: Intravenous morphine and oral oxycodone; Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12hrs VAS Pain Scores	Visual Analog Scale; 0-10 (10 indicates highest degree of pain)	Measured at postoperative hour 12
24hrs VAS Pain Score	Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain)	Measured at postoperative hour 24
36hrs VAS Pain Scores	Visual Analog Scale; 0-10 (10 indicates highest degree of pain)	Measured at postoperative hour 36
48hrs VAS Pain Scores	Visual Analog Scale; 0-10 (10 indicates highest degree of pain)	Measured at postoperative hour 48
12hrs MME	Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME)	Measured at postoperative hour 12
24hrs MME	Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME)	Measured at postoperative hour 24
36hrs MME	Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME)	Measured at postoperative hour 36
48hrs MME	Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME)	Measured at postoperative hour 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Time from intervention to discharge	Determined by discharge date

Collaborators and Investigators

• Sponsor: University of Puerto Rico
• Investigators: Principal Investigator: Luis F. Lojo-Sojo, MD, Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Post-operative pain; Femur fracture; Analgesic use; Opioid use; Intramedullary Nailing; Tibia fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Tibial Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Analgesics, Opioid; Narcotics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Acetaminophen; Morphine; Ketorolac; Oxycodone
• Other Study ID Numbers: A9290220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No