Back to resultsEffects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption
Primary Purpose
Compartment Syndrome of Leg
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient education
Sponsored by
About this trial
This is an interventional supportive care trial for Compartment Syndrome of Leg
Eligibility Criteria
Inclusion Criteria:
Patients with lower extremity trauma at risk for developing compartment syndrome specifically tibial plateau fractures, tibial/fibular shaft fractures, pilon fractures, and crush injuries.
Exclusion Criteria:
Patients with an extensive history of narcotic medication or drug use, polytrauma patients, and non-primary English speaking patients
Sites / Locations
- Rothman Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
No patient education
Patient education
Arm Description
This group of patients will not receive any additional information beyond standard of care educational pamphlets provided by the hospital.
This group of patients will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.
Outcomes
Primary Outcome Measures
narcotic consumption
Perioperative
Secondary Outcome Measures
Full Information
NCT ID
NCT03359031
First Posted
November 27, 2017
Last Updated
November 27, 2017
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT03359031
Brief Title
Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption
Official Title
Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 13, 2017 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is a prospective, randomized trial. Our study aims to study the effects of perioperative patient education about compartment syndrome on patients' perception of their own pain, amount of opioid medication utilization, and rate of diagnosis of compartment syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compartment Syndrome of Leg
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No patient education
Arm Type
No Intervention
Arm Description
This group of patients will not receive any additional information beyond standard of care educational pamphlets provided by the hospital.
Arm Title
Patient education
Arm Type
Other
Arm Description
This group of patients will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.
Intervention Type
Other
Intervention Name(s)
Patient education
Intervention Description
This group will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.
Primary Outcome Measure Information:
Title
narcotic consumption
Description
Perioperative
Time Frame
total opioid consumption from surgery through 30 days post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with lower extremity trauma at risk for developing compartment syndrome specifically tibial plateau fractures, tibial/fibular shaft fractures, pilon fractures, and crush injuries.
Exclusion Criteria:
Patients with an extensive history of narcotic medication or drug use, polytrauma patients, and non-primary English speaking patients
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption
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