Opioid-Free Pain Treatment in Trauma Patients

University of Kansas

Status: Enrolling

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

Treatments: Other: Opioid-free pain treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06078371

STUDY00149431

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is over the age of 18 years old
• Underwent surgical treatment for the injuries of interest (stated elsewhere) by an Orthopedic Traumatology Attending Physician at the University of Kansas Hospital

Exclusion criteria

• Patients that are unable to provide informed consent due to sustaining a head injury or incoherence from narcotics given to them post-injury
• Chronic opioid use
• Under the age of 18 years old
• Undergoing revision surgery
• Did not undergo surgical fixation
• Pregnant/nursing women
• Vulnerable populations as defined by the University of Kansas Medical Center IRB
• Did not experience one of the following fractures listed in D.1. above.
• 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Opioid pain treatment (Block 1)

No Intervention group

Description:

Standard of care pain treatment regimen that involves the use of opioids. Discretion of the medical care team and surgeon will be used for specific opioid pain treatment prescription (quantity, frequency) based on standard of care procedures. All forms of treatment are allowed for the standard of care group which may include but are not limited to blocks, opioids, patient-controlled analgesia, NSAIDs, acetaminophen, muscle relaxing agents, sedation medications, and neuropathic pain medications.

Opioid-Free pain treatment (Block 2)

Experimental group

Description:

Pain treatment regiment without the use of opioids. All other pain medication may be used under the discretion of the medical care team and surgeon.

Treatment:

Other: Opioid-free pain treatment