Actively Recruiting
Peri-operative Opioid-free Analgesic Protocol for Orthopedic Trauma Patients
Led by University of Kansas Medical Center · Updated on 2024-10-26
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating pain outcomes in patients who have had surgery for various orthopedic fractures, comparing opioid-based pain management with opioid-free pain management. This randomized trial aims to understand differences in pain scores and other health factors up to six months after surgery. The study is conducted at a single center and includes adults who have undergone surgical treatment for specific fractures. Participants will be assigned to one of two groups based on the timing of their surgery. One group will receive standard pain treatment that may include opioids and other medications as decided by their medical team. The other group will receive pain management excluding opioids but may use other medications. Patients with kidney or liver problems initially assigned to the opioid-free group will switch to the opioid group for safety reasons. Both groups will follow the same surgical care protocols apart from pain management. During the study, participants will be monitored for pain levels using a numerical rating scale from surgery up to six months afterward. Researchers will also track medication use, surgical complications, and other health factors such as age, sex, and smoking status. Safety monitoring includes checks for blood clots and wound healing, with standard medical care continuing throughout the study.
CONDITIONS
Brief Title
Opioid-Free Pain Treatment in Trauma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is over the age of 18 years old
- Underwent surgical treatment for the injuries of interest by an Orthopedic Traumatology Attending Physician at the University of Kansas Hospital
You will not qualify if you...
- Unable to provide informed consent due to head injury or narcotic effects
- Chronic opioid use
- Under the age of 18 years old
- Undergoing revision surgery
- Did not undergo surgical fixation
- Pregnant or nursing women
- Vulnerable populations as defined by the University of Kansas Medical Center IRB
- Did not experience one of the specified fractures
- Patients with chronic kidney disease or cirrhosis excluded from the opioid-free pain group
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at the time of surgical consent
Duration - Perioperative period including surgery and immediate recovery
Participants undergo surgical treatment for orthopedic trauma and receive assigned pain management protocol without or with opioids depending on block assignment.
1 hospitalization period including surgery and immediate post-operative monitoring
Duration - Up to 6 months post surgery
Participants are monitored for pain levels, complications, and medication usage up to 6 months after surgery.
Regular follow-up visits as per institutional protocols
Trial Site Locations
Total: 1 location
1
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66103
Actively Recruiting
Research Team
A
Archie Heddings, MD
D
Dave Turkowitch, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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