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

Phase 4

Completed

Conditions: Tibial Fractures
Femur Fracture

Interventions: Other: Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture
Drug: Intravenous ketorolac and oral acetaminophen
Drug: Intravenous morphine and oral oxycodone

Registration Number: NCT04761302

Lead Sponsor: University of Puerto Rico

Brief 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.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 167

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: 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	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.
Group 2: Intravenous Morphine and oral oxycodone	Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture	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.
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and oral acetaminophen	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.
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and oral oxycodone	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.
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen	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.
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and oral oxycodone	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.

Primary Outcome Measures

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