Opioid-Free Pain Treatment in Trauma Patients

Femoral Neck Fractures Clinical Trial

Official title:

Peri-operative Opioid-free Analgesic Protocol for Orthopedic Trauma Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06078371
• Other study ID #: STUDY00149431
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: University of Kansas Medical Center
• Contact: Archie Heddings, MD
• Phone: 913-588-6164
• Email: aheddings[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 undergoing treatment of the above-mentioned fractures with normal standard of care pain management protocol (pre-, intra-, and postoperatively). The second block will consist of patients undergoing treatment the same fractures with opioid-free pain management protocol (pre-, intra-, and postoperatively). Block selection will be determined based on the date of the surgery. However, patients initially assigned to the opioid-free protocol that have CKD/laboratory evidence of poor renal function (ie, elevated BUN/Creatinine) or laboratory evidence of liver function issues (ie, cirrhosis, hypoalbuminemia, elevated liver transaminases, elevated GGT) will crossover to the opioid group as NSAID use and acetaminophen use, respectively, are contraindicated. The use of block randomization will preclude the need for the study coordinator to perform any sort of individual randomization or sealed envelope use for treatment assignment. For subjects who meet eligibility criteria, study informed consent will be obtained at the same time as surgical consent. Those in the standard of care study block will undergo KUMC's normal pain management strategy. Those in the opioid-free study block will receive the same pain-management drugs as the opioid group aside from recieving opioids; all other medical care will be standard in this group. Postoperative weightbearing, immobilization, perioperative antibiotics, drain usage, and discharge criteria will be determined by institutional protocols and will remain the same for each block. All patients will be started on postoperative chemical anticoagulation prophylaxis as determined by their fracture pattern and medical comorbidities. Patients will be clinically monitored for signs of venous thromboembolism and appropriate diagnostic screening will be utilized as necessary. Wound complications will be monitored by the treating surgeon and managed as necessary. We also plan to record patient specific factors including age, sex, BMI, smoking status, comorbidities, and operative time. These variables will be analyzed independently to detect any correlation with the two pain management protocols.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Ankle Fractures
• Calcaneus Fractures
• Clavicle Fractures
• Distal Femur Fracture
• Distal Radius Fractures
• Elbow Fractures
• Femoral Neck Fractures
• Femoral Shaft Fracture
• Fractures, Bone
• Hip Fractures
• Humeral Fractures
• Intertrochanteric Fractures
• Lisfranc Injuries
• Olecranon Fracture
• Patella Fracture
• Proximal Humerus Fractures
• Radius Fractures
• Wrist Fractures

Intervention

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

Locations

Country	Name	City	State
United States	The University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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