Clinical trial NCT06078371: Opioid-Free Pain Treatment in Trauma Patients
Official title: Peri-operative Opioid-free Analgesic Protocol for Orthopedic Trauma Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Keywords: Surgical Intervention
Trauma
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted using block randomization, with two six-month blocks of patient enrollment. Block selection will be determined based on the date of the surgery.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Numerical Rating Scale (NRS) Pain Scores
timeFrame: From post surgery up until 6 months post surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: From post surgery up until 6 months post surgery
measure: Medication usage (timing)
timeFrame: From post surgery up until 6 months post surgery
measure: Medication usage (quantity)
timeFrame: From post surgery up until 6 months post surgery
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
Study officials:
References: