Opioid-Free Pain Treatment in Trauma Patients

October 5, 2023 updated by: Archie Heddings, MD, University of Kansas Medical Center

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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. 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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • The University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Archie Heddings, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Opioid pain treatment (Block 1)
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.
Experimental: Opioid-Free pain treatment (Block 2)
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.
Other: Opioid-free pain treatment
Pain treatment includes any medications up to the medical team's discretion aside from opioids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS) Pain Scores
Time Frame: From post surgery up until 6 months post surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: From post surgery up until 6 months post surgery
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
Medication usage (timing)
Time Frame: From post surgery up until 6 months post surgery
The duration of which analgesia is used to treat post-surgical pain will be measured
From post surgery up until 6 months post surgery
Medication usage (quantity)
Time Frame: From post surgery up until 6 months post surgery
The dosage of analgesia used to treat post-surgical pain will be measured
From post surgery up until 6 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00149431

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Femoral Neck Fractures

Clinical Trials on Opioid-free pain treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe