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Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03359031
Recruitment Status : Unknown
Verified November 2017 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : December 2, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Compartment Syndrome of Leg Other: Patient education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: No patient education
This group of patients will not receive any additional information beyond standard of care educational pamphlets provided by the hospital.
Patient education
This group of patients will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.
 Other: Patient education
This group will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.


Outcome Measures
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Primary Outcome Measures :
  1. narcotic consumption [ Time Frame: total opioid consumption from surgery through 30 days post-op ]
    Perioperative


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359031


Locations
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United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT03359031    
Other Study ID Numbers: 2017-Krieg
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Compartment Syndromes
Syndrome
Disease
Pathologic Processes
 Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases