Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption
1 other identifier
interventional
134
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 13, 2017
CompletedFirst Submitted
Initial submission to the registry
November 27, 2017
CompletedFirst Posted
Study publicly available on registry
December 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedDecember 2, 2017
November 1, 2017
12 months
November 27, 2017
November 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
narcotic consumption
Perioperative
total opioid consumption from surgery through 30 days post-op
Study Arms (2)
No patient education
NO INTERVENTIONThis group of patients will not receive any additional information beyond standard of care educational pamphlets provided by the hospital.
Patient education
OTHERThis group of patients will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.
Interventions
This group will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.
Eligibility Criteria
You may qualify if:
- Patients with lower extremity trauma at risk for developing compartment syndrome specifically tibial plateau fractures, tibial/fibular shaft fractures, pilon fractures, and crush injuries.
You may not qualify if:
- Patients with an extensive history of narcotic medication or drug use, polytrauma patients, and non-primary English speaking patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2017
First Posted
December 2, 2017
Study Start
November 13, 2017
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
December 2, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share