Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption
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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
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Condition or disease | Intervention/treatment | Phase |
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Compartment Syndrome of Leg | Other: Patient education | Not Applicable |
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 |

Arm | Intervention/treatment |
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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.
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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.
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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. |
- narcotic consumption [ Time Frame: total opioid consumption from surgery through 30 days post-op ]Perioperative

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

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
United States, Pennsylvania | |
Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Compartment Syndromes Syndrome Disease Pathologic Processes |
Muscular Diseases Musculoskeletal Diseases Vascular Diseases Cardiovascular Diseases |