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

November 27, 2017 updated by: Rothman Institute Orthopaedics
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
narcotic consumption
Time Frame: total opioid consumption from surgery through 30 days post-op
Perioperative
total opioid consumption from surgery through 30 days post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2017

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

December 2, 2017

Study Record Updates

Last Update Posted (Actual)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-Krieg

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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