Femoral Neck Fractures Clinical Trial
Official title:
Peri-operative Opioid-free Analgesic Protocol for Orthopedic Trauma Patients
Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.
Status | Not yet recruiting |
Enrollment | 250 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients (over the age of 18 years old) who undergo surgical treatment for the injuries of interest (stated elsewhere) by an Orthopedic Traumatology Attending Physician at the University of Kansas Hospital will be identified and offered the opportunity to participate in the study. Exclusion Criteria: - i. Patients that are unable to provide informed consent due to sustaining a head injury or incoherence from narcotics given to them post-injury ii. Chronic opioid use iii. Under the age of 18 years old iv. Undergoing revision surgery v. Did not undergo surgical fixation vi. Pregnant/nursing women vii. Vulnerable populations as defined by the University of Kansas Medical Center IRB viii. Did not experience one of the following fractures listed in D.1. above. ix. 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) |
Country | Name | City | State |
---|---|---|---|
United States | The University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numerical Rating Scale (NRS) Pain Scores | Patients will be asked how much pain they are experiencing on a 1-10 scale after their surgery. | From post surgery up until 6 months post surgery | |
Secondary | 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. | From post surgery up until 6 months post surgery | |
Secondary | Medication usage (timing) | The duration of which analgesia is used to treat post-surgical pain will be measured | From post surgery up until 6 months post surgery | |
Secondary | Medication usage (quantity) | The dosage of analgesia used to treat post-surgical pain will be measured | From post surgery up until 6 months post surgery |
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