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

NCT04761302 | Completed Phase 4 Results FDA Drug

• 1 other identifier: A9290220
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Femur Fracture; Tibial Fractures

Keywords

Opioid use; Post-operative pain; Analgesic use; Femur fracture; Tibia fracture; Intramedullary Nailing

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Hospital Length of Stay

  Determined by discharge date

Study Arms (4)

Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and oral acetaminophen

EXPERIMENTAL

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

Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and oral oxycodone

ACTIVE COMPARATOR

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

Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen

EXPERIMENTAL

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

Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and oral oxycodone

ACTIVE COMPARATOR

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

Interventions

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

Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and oral acetaminophen; Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen

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.

Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and oral oxycodone; Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and oral oxycodone

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

University District Hospital

San Juan, 00936, Puerto Rico

Location

Related Publications (1)

• Hess-Arcelay H, Claudio-Marcano A, Torres-Lugo NJ, Deliz-Jimenez D, Acosta-Julbe J, Hernandez G, Deliz-Jimenez D, Monge G, Ramirez N, Lojo-Sojo L. Opioid-Sparing Nonsteroid Anti-inflammatory Drugs Protocol in Patients Undergoing Intramedullary Nailing of Tibial Shaft Fractures: A Randomized Control Trial. J Am Acad Orthop Surg. 2024 Jun 15;32(12):e596-e604. doi: 10.5435/JAAOS-D-23-01014. Epub 2024 Apr 4.

  PMID: 38579315 DERIVED

MeSH Terms

Conditions

Femoral Fractures; Tibial Fractures; Pain, Postoperative

Interventions

Acetaminophen; Oxycodone

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Hans Hess
• Organization: University of Puerto Rico: Department of Orthopedic Surgery

hans.hess1@upr.edu

787-365-5755

Study Officials

• Luis F. Lojo-Sojo, MD

  Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 18, 2021
• Study Start: April 18, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)