Opioid-Free Pain Treatment in Trauma Patients

{ "Opioid-Free Pain Treatment for Trauma Patients", "This study is looking at different ways to manage pain after surgery for certain broken bones, specifically in the hip and thigh (femoral neck, intertrochanteric, femoral shaft, distal femur, and patella fractures). Researchers want to compare how well pain is controlled using standard pain medications (which can include opioids) versus an \"opioid-free pain treatment\" plan. You might be able to join if you are over 18, are having surgery for one of these fractures at the University of Kansas Hospital, and can give your consent. The main goal is to see how your pain levels change from right after surgery up to 6 months later. The study is currently unclear about its recruitment status and plans to enroll 250 people.", "design": "This is an interventional study that will randomly assign 250 participants into two groups over two six-month periods. One group will receive standard pain management, and the other will receive opioid-free pain management.", "commitments": "You would receive pain treatment as determined by the study protocol, either standard care or opioid-free. Your pain levels will be measured from after surgery up to 6 months later.", "compensation": "Not stated in the trial record.", "follow_up": "Your pain levels will be monitored for up to 6 months after surgery.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06078371

Opioid-Free Pain Treatment in Trauma Patients

Recruiting
NAAges 18+InterventionalSupportive care
University of Kansas Medical Center
~250 participants
Updated 2024-10-26 on ClinicalTrials.gov
What's tested:Opioid-free pain treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Numerical Rating Scale (NRS) Pain Scores
Measured over From post surgery up until 6 months post surgery
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

NCT06078371

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The University of Kansas Medical Center

    Kansas City, Kansasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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)
  • Numerical Rating Scale (NRS) Pain ScoresFrom post surgery up until 6 months post surgery

    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.