Recruiting

Opioid-Free Pain Treatment

Sponsor:

University of Kansas Medical Center

Code:

NCT06078371

Conditions

Femoral Neck Fractures

Intertrochanteric Fractures

Femoral Shaft Fracture

Distal Femur Fracture

Patella Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Opioid-free pain treatment

Study Details

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

Study ID

NCT06078371

Start date

Nov 1, 2023

Status verified date

Oct, 2024

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Opioid-free pain treatment

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Archie Heddings, MD

913-588-6164aheddings@kumc.edu

Dave Turkowitch, BS

dturkowitch@kumc.edu

Locations

The University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66103

Contacts

Dave Turkowitch, BS

dturkowitch@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Oct 26, 2024

Last verified

Oct, 2024

Keywords

  • Surgical Intervention
  • Trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2024-10-26.