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

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerardo Olivella, MD, MPH; Phone Number: 7877645095; Email: gerardo.olivella@upr.edu
• Study Contact Backup: Name: Hans Hess Arcelay, MD; Phone Number: 7873655755; Email: hans.hess1@upr.edu

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Intravenous Ketorolac and oral acetaminophen; Group 1 will be composed of 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.	Other: Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture; This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
Active Comparator: Group 2: Intravenous Morphine and oral oxycodone; Group 2 will be composed of 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.	Other: Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture; This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores using numerical rating scale (NRS, 0 to 10)	Pre-operative holding area	Three to five days
Pain scores using numerical rating scale (NRS, 0 to 10)	Post-operative 12 hours	Three to five days
Pain scores using numerical rating scale (VAS, 0 to 10)	Post-operative 24 hours	Three to five days
Pain scores using numerical rating scale (VAS, 0 to 10)	Post-operative 36 hours	Three to five days
Pain scores using numerical rating scale (VAS, 0 to 10)	Post-operative 48 hours	Three to five days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events related to postoperative pain drugs	Describe possible drug related complications such as: headache, nausea, vomit, dizziness, pruritus, urinary retention, constipation, gastrointestinal bleeding, cardiovascular complications, respiratory complications, delirium, among others	Zero to 72 hours postoperative
Cumulative Opioid Consumption	Recorded postoperative after discharge	Zero to 72 hours postoperative
Hospital Length of Stay	Time from intervention to discharge	1 to 5 days

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): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

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: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Pain, Postoperative; Femoral Fractures; Fractures, Bone; Tibial Fractures; Anti-Inflammatory Agents
• 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: No
• Studies a U.S. FDA-regulated device product: No