New Mechatronic Device for Epidural Space Detection

Campus Bio-Medico University of Rome

Status: Completed

Conditions: Non Invasive Monitoring of Loss of Resistance During Epidural Injection

Treatments: Device: LOR measurement via device

Study type: Interventional

Funder types: Other

Identifiers

NCT03589391

EPISENS

Details and patient eligibility

About

This study sought to perform the feasibility assessment of a new, non-invasive device for Loss of Resistance (LOR) detection in clinical settings. The device in charge is a mechatronic device optimized in its configurations in order to detect Loss of Resistance while performing epidural injections.

Enrollment: 34 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients whose pathology requires specific treatment such as epidural infiltration

Exclusion criteria

• coagulation abnormalities or assumption of anticoagulant drugs

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Procedures with the use of device for LOR monitoring

Experimental group

Description:

Patients enrolled suffered from chronic back pain and underwent epidural infiltration. The device is used.

Treatment:

Device: LOR measurement via device

Procedures without the use of device for LOR monitoring

No Intervention group

Description:

Patients enrolled suffered from chronic back pain and underwent epidural infiltration