Opioid-Free Pain Treatment in Trauma Patients

Femoral Neck Fractures Clinical Trial

Official title: Peri-operative Opioid-free Analgesic Protocol for Orthopedic Trauma Patients

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

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

• NCT number: NCT06078371
• Study type: Interventional
• Source: University of Kansas Medical Center
• Contact: Archie Heddings, MD
• Phone: 913-588-6164
• Email: aheddings@kumc.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Completion date: October 2024