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

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Unknown status

CT.gov ID

NCT03359031

Collaborator

(none)

134

Enrollment

Location

Arms

11.6

Anticipated Duration (Months)

11.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Compartment Syndrome of Leg	Other: Patient education	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 13, 2017

Anticipated Primary Completion Date :

Nov 1, 2018

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

narcotic consumption [total opioid consumption from surgery through 30 days post-op]
Perioperative

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Rothman Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT03359031

Other Study ID Numbers:

2017-Krieg

First Posted:

Dec 2, 2017

Last Update Posted:

Dec 2, 2017

Last Verified:

Nov 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Compartment Syndromes

Syndrome

Study Results

No Results Posted as of Dec 2, 2017