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

Study Overview
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Brief Summary
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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.

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

Conditions
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Femur Fracture, Tibial Fractures

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Intravenous Ketorolac and oral acetaminophen<br>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<br>* 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.<br>|
| Active Comparator: Group 2: Intravenous Morphine and oral oxycodone<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid use, Post-operative pain, Analgesic use, Femur fracture, Tibia fracture, Intramedullary Nailing