Health TrialsbyHealthPanel

Opioid-Free Pain Treatment in Trauma Patients

ConditionsFemoral Neck FracturesIntertrochanteric FracturesFemoral Shaft FractureDistal Femur FracturePatella FractureTibial Shaft Fracture with or Without Associated Fibula FractureAnkle Fracture (bimalleolar Equivalent, Bimalleolar, or Trimalleolar)Tibial Pilon FractureTalar Head, Neck, Body, or Process FracturesCalcaneus FracturesLisfranc InjuriesIsolated or Multiple Metatarsal FracturesPhalanx Fractures of the Foot, Single or MultipleClavicle FracturesProximal Humerus FracturesHumeral Shaft FracturesDistal Humerus Fractures (intra or Extra-articular)Olecranon FracturesRadial Head or Neck FracturesElbow Fractures Involving a Combination of Fractures of the Radius and UlnForearm Fractures (both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)Distal Radius Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Opioid-free pain treatment

    Other intervention

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

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Opioid pain treatment (Block 1)No intervention 0 interventions
Group B: Opioid-Free pain treatment (Block 2)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
From post surgery up until 6 months post surgery

Secondary outcomes

1

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.

Time frame
From post surgery up until 6 months post surgery
2

Medication usage (timing)

The duration of which analgesia is used to treat post-surgical pain will be measured

Time frame
From post surgery up until 6 months post surgery
3

Medication usage (quantity)

The dosage of analgesia used to treat post-surgical pain will be measured

Time frame
From post surgery up until 6 months post surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Kansas Medical Center

Lead sponsor

Source ClinicalTrials.gov
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