Status:
RECRUITING
Opioid-Free Pain Treatment in Trauma Patients
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Femoral Neck Fractures
Intertrochanteric Fractures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.
Detailed Description
This will be a single center randomized trial. The study will be conducted using block randomization, with two six-month blocks of patient enrollment. The first block will consist of patients undergoi...
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)
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06078371
Start Date
November 1 2023
End Date
October 1 2026
Last Update
October 26 2024
Active Locations (1)
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1
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66103