Opioid-Free Pain Treatment in Trauma Patients

NCT06078371 | Recruiting DMC

• 1 other identifier: STUDY00149431
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Keywords

Surgical Intervention; Trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative complications

  From post surgery up until 6 months post surgery

• Medication usage (timing)

  From post surgery up until 6 months post surgery

• Medication usage (quantity)

  From post surgery up until 6 months post surgery

Study Arms (2)

Opioid pain treatment (Block 1)

NO INTERVENTION

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.

Opioid-Free pain treatment (Block 2)

EXPERIMENTAL

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

Interventions

Opioid-free pain treatment OTHER

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

Opioid-Free pain treatment (Block 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

RECRUITING

MeSH Terms

Conditions

Femoral Neck Fractures; Hip Fractures; Femoral Fractures, Distal; Patella Fracture; Ankle Fractures; Humeral Fractures, Distal; Olecranon Fracture; Radial Head and Neck Fractures; Wrist Fractures; Wounds and Injuries

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Hip Injuries; Leg Injuries; Knee Fractures; Ankle Injuries; Elbow Fractures; Elbow Injuries; Arm Injuries; Humeral Fractures; Ulna Fractures; Forearm Injuries; Radius Fractures; Wrist Injuries

Central Study Contacts

Archie Heddings, MD

CONTACT

913-588-6164; aheddings@kumc.edu

Dave Turkowitch, BS

CONTACT

dturkowitch@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study will be conducted using block randomization, with two six-month blocks of patient enrollment. Block selection will be determined based on the date of the surgery.

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

US (1)