NCT06078371

Opioid-Free Pain Treatment in Trauma Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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. Patients in the standard of care study block will undergo KUMC's normal pain management strategy. Patients in the opioid-free study block will receive the same pain-management drugs as the opioid group aside from receiving 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. The study team also plans 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.

Conditions

• Femoral Neck Fractures
• Intertrochanteric Fractures
• Femoral Shaft Fracture
• Distal Femur Fracture
• Patella Fracture
• Tibial Shaft Fracture with or Without Associated Fibula Fracture
• Ankle Fracture (bimalleolar Equivalent, Bimalleolar, or Trimalleolar)
• Tibial Pilon Fracture
• Talar Head, Neck, Body, or Process Fractures
• Calcaneus Fractures
• Lisfranc Injuries
• Isolated or Multiple Metatarsal Fractures
• Phalanx Fractures of the Foot, Single or Multiple
• Clavicle Fractures
• Proximal Humerus Fractures
• Humeral Shaft Fractures
• Distal Humerus Fractures (intra or Extra-articular)
• Olecranon Fractures
• Radial Head or Neck Fractures
• Elbow Fractures Involving a Combination of Fractures of the Radius and Uln
• Forearm Fractures (both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)
• Distal Radius Fractures

Interventions

Type	Name	Description
OTHER	Opioid-free pain treatment	Pain treatment includes any medications up to the medical team's discretion aside from opioids.

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-10-11
• Last updated: 2024-10-26

Locations

1 site across 1 country: United States