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Opioid-Free Pain Treatment in Trauma Patients

Primary Purpose

Femoral Neck Fractures, Intertrochanteric Fractures, Femoral Shaft Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opioid-free pain treatment
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Femoral Neck Fractures focused on measuring Surgical Intervention, Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Opioid pain treatment (Block 1)

Opioid-Free pain treatment (Block 2)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Numerical Rating Scale (NRS) Pain Scores
Patients will be asked how much pain they are experiencing on a 1-10 scale after their surgery.

Secondary Outcome Measures

Postoperative complications
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.
Medication usage (timing)
The duration of which analgesia is used to treat post-surgical pain will be measured
Medication usage (quantity)
The dosage of analgesia used to treat post-surgical pain will be measured

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06078371
Brief Title
Opioid-Free Pain Treatment in Trauma Patients
Official Title
Peri-operative Opioid-free Analgesic Protocol for Orthopedic Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Opioid pain treatment (Block 1)
Arm Type
No Intervention
Arm 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.
Arm Title
Opioid-Free pain treatment (Block 2)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Opioid-free pain treatment
Intervention Description
Pain treatment includes any medications up to the medical team's discretion aside from opioids.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) Pain Scores
Description
Patients will be asked how much pain they are experiencing on a 1-10 scale after their surgery.
Time Frame
From post surgery up until 6 months post surgery
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
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.
Time Frame
From post surgery up until 6 months post surgery
Title
Medication usage (timing)
Description
The duration of which analgesia is used to treat post-surgical pain will be measured
Time Frame
From post surgery up until 6 months post surgery
Title
Medication usage (quantity)
Description
The dosage of analgesia used to treat post-surgical pain will be measured
Time Frame
From post surgery up until 6 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Archie Heddings, MD
Phone
913-588-6164
Email
aheddings@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dave Turkowitch, BS
Email
dturkowitch@kumc.edu
Facility Information:
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66103
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dave Turkowitch, BS
Email
dturkowitch@kumc.edu
First Name & Middle Initial & Last Name & Degree
Archie Heddings, MD

12. IPD Sharing Statement

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Opioid-Free Pain Treatment in Trauma Patients

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