Opioid-Free Pain Treatment in Trauma Patients

Peri-operative Opioid-free Analgesic Protocol for Orthopedic Trauma Patients

Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.

Study Overview

• Status: Recruiting
• Conditions: Femoral Neck Fractures; Distal Radius Fractures; Femoral Shaft Fracture; Intertrochanteric Fractures; Patella Fracture; Lisfranc Injuries; Distal Femur Fracture; Calcaneus Fractures; Clavicle Fractures; Proximal Humerus Fractures; Tibial Pilon Fracture; Talar Head, Neck, Body, or Process Fractures; Isolated or Multiple Metatarsal Fractures; Phalanx Fractures of the Foot, Single or Multiple; Humeral Shaft Fractures; Olecranon Fractures; Radial Head or Neck Fractures; Elbow Fractures Involving a Combination of Fractures of the Radius and Uln; Tibial Shaft Fracture with or Without Associated Fibula Fracture; Ankle Fracture (bimalleolar Equivalent, Bimalleolar, or Trimalleolar); Distal Humerus Fractures (intra or Extra-articular); Forearm Fractures (both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)
• Intervention / Treatment: Other: Opioid-free pain treatment

Detailed Description

This will be a single center randomized trial. The study will be conducted using block randomization, with two six-month blocks of patient enrollment. The first block will consist of patients undergoing treatment of the above-mentioned fractures with normal standard of care pain management protocol (pre-, intra-, and postoperatively). The second block will consist of patients undergoing treatment the same fractures with opioid-free pain management protocol (pre-, intra-, and postoperatively). Block selection will be determined based on the date of the surgery. However, patients initially assigned to the opioid-free protocol that have CKD/laboratory evidence of poor renal function (ie, elevated BUN/Creatinine) or laboratory evidence of liver function issues (ie, cirrhosis, hypoalbuminemia, elevated liver transaminases, elevated GGT) will crossover to the opioid group as NSAID use and acetaminophen use, respectively, are contraindicated. The use of block randomization will preclude the need for the study coordinator to perform any sort of individual randomization or sealed envelope use for treatment assignment. For subjects who meet eligibility criteria, study informed consent will be obtained at the same time as surgical consent. Patients in the standard of care study block will undergo KUMC's normal pain management strategy. Patients in the opioid-free study block will receive the same pain-management drugs as the opioid group aside from receiving opioids; all other medical care will be standard in this group. Postoperative weightbearing, immobilization, perioperative antibiotics, drain usage, and discharge criteria will be determined by institutional protocols and will remain the same for each block. All patients will be started on postoperative chemical anticoagulation prophylaxis as determined by their fracture pattern and medical comorbidities. Patients will be clinically monitored for signs of venous thromboembolism and appropriate diagnostic screening will be utilized as necessary. Wound complications will be monitored by the treating surgeon and managed as necessary. The study team also plans to record patient specific factors including age, sex, BMI, smoking status, comorbidities, and operative time. These variables will be analyzed independently to detect any correlation with the two pain management protocols.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Archie Heddings, MD; Phone Number: 913-588-6164; Email: aheddings@kumc.edu
• Study Contact Backup: Name: Dave Turkowitch, BS; Email: dturkowitch@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • Recruiting
      • The University of Kansas Medical Center
      • Contact: Dave Turkowitch, BS; Email: dturkowitch@kumc.edu
      • Contact: Archie Heddings, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is over the age of 18 years old
• Underwent surgical treatment for the injuries of interest (stated elsewhere) by an Orthopedic Traumatology Attending Physician at the University of Kansas Hospital

Exclusion Criteria:

• Patients that are unable to provide informed consent due to sustaining a head injury or incoherence from narcotics given to them post-injury
• Chronic opioid use
• Under the age of 18 years old
• Undergoing revision surgery
• Did not undergo surgical fixation
• Pregnant/nursing women
• Vulnerable populations as defined by the University of Kansas Medical Center IRB
• Did not experience one of the following fractures listed in D.1. above.
• Patients with CKD and/or cirrhosis will be excluded from the opioid-free pain block (block 2) and will only qualify for the standard of care opioid group (Block 1)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Opioid pain treatment (Block 1); Standard of care pain treatment regimen that involves the use of opioids. Discretion of the medical care team and surgeon will be used for specific opioid pain treatment prescription (quantity, frequency) based on standard of care procedures. All forms of treatment are allowed for the standard of care group which may include but are not limited to blocks, opioids, patient-controlled analgesia, NSAIDs, acetaminophen, muscle relaxing agents, sedation medications, and neuropathic pain medications.
Experimental: Opioid-Free pain treatment (Block 2); Pain treatment regiment without the use of opioids. All other pain medication may be used under the discretion of the medical care team and surgeon.	Other: Opioid-free pain treatment; Pain treatment includes any medications up to the medical team's discretion aside from opioids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS) Pain Scores	Patients will be asked how much pain they are experiencing on a 1-10 scale after their surgery. Lower scores mean better outcomes and less pain, higher scores mean worse outcomes.	From post surgery up until 6 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Data will be collected on the presence or absence of various complications due to surgery that include: acute kidney injury, subsequent reoperation, amputation, compartment syndrome, surgical site infection, wound dehiscence, nonunion, or venous thromboembolism.	From post surgery up until 6 months post surgery
Medication usage (timing)	The duration of which analgesia is used to treat post-surgical pain will be measured	From post surgery up until 6 months post surgery
Medication usage (quantity)	The dosage of analgesia used to treat post-surgical pain will be measured	From post surgery up until 6 months post surgery

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Trauma; Surgical Intervention
• Additional Relevant MeSH Terms: Elbow Injuries; Knee Fractures; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Arm Injuries; Ankle Injuries; Forearm Injuries; Wrist Injuries; Ulna Fractures; Wrist Fractures; Elbow Fractures; Femoral Fractures, Distal; Olecranon Fracture; Humeral Fractures, Distal; Patella Fracture; Fibula Fractures; Fractures, Bone; Ankle Fractures; Hip Fractures; Humeral Fractures; Femoral Neck Fractures; Radius Fractures; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: STUDY00149431

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No