Opioid-Free Pain Treatment in Trauma Patients

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06078371
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Opioid-free pain treatment — OTHER
    Pain treatment includes any medications up to the medical team's discretion aside from opioids.

Study Details

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

Key Dates

Start date
Nov 1, 2023
Status verified
Oct 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Numerical Rating Scale (NRS) Pain Scores [ Time Frame: From post surgery up until 6 months post surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Kansas Medical CenterKansas CityKansas66103
Dave Turkowitch, BS
[email protected]
Archie Heddings, MD

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By research site
The University of Kansas Medical Center· Kansas City, KS

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