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History of Changes for Study: NCT03359031
Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption
Latest version (submitted November 27, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 27, 2017 None (earliest Version on record)
Comparison Format:

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Study NCT03359031
Submitted Date:  November 27, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2017-Krieg
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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2017
Overall Status: Unknown status [Previously: Enrolling by invitation]
Study Start: November 13, 2017
Primary Completion: November 2018 [Anticipated]
Study Completion: November 2018 [Anticipated]
First Submitted: November 27, 2017
First Submitted that
Met QC Criteria:
November 27, 2017
First Posted: December 2, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
November 27, 2017
Last Update Posted: December 2, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Rothman Institute Orthopaedics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Compartment Syndrome of Leg
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 134 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Patient education
This group will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. narcotic consumption
[ Time Frame: total opioid consumption from surgery through 30 days post-op ]

Perioperative
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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

Open or close this module Contacts/Locations
Locations: United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services