Opioid-Free Pain Treatment in Trauma Patients

NCT ID: NCT06078371

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-10-31

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Opioid-free pain treatment

Intervention Type: OTHER

Pain treatment includes any medications up to the medical team's discretion aside from opioids.

Interventions

Opioid-free pain treatment

Pain treatment includes any medications up to the medical team's discretion aside from opioids.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Archie Heddings, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Archie Heddings, MD

Role: CONTACT

aheddings@kumc.edu

913-588-6164

Dave Turkowitch, BS

Role: CONTACT

dturkowitch@kumc.edu

Facility Contacts

Dave Turkowitch, BS

Role: primary

dturkowitch@kumc.edu

Archie Heddings, MD

Role: backup

Other Identifiers

STUDY00149431

Identifier Type: -

Identifier Source: org_study_id