Epidrum for Thoracic Epidural Analgesia

A Comparison Study of Two Different Techniques for Identifying the Epidural Space in Patients Requiring Thoracic Epidural Analgesia: a Prospective Multicentric Randomized Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01597466

Acronym

Epidrum-Tho

Enrollment

Registered

2012-05-14

Start date

2013-04-30

Completion date

2015-06-30

Last updated

2016-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

The purpose of this study is to evaluate the use of the Epidrum device to identify the epidural space in patients requiring thoracic epidural analgesia.

Interventions

DEVICEEpidural catheter placement

Epidural space is located using Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Elective major thoracic surgery requiring thoracic epidural analgesia

Exclusion criteria

* Contraindication to epidural anesthesia * Marked spinal deformities or a history of spinal instrumentation

Design outcomes

Primary

Measure	Time frame	Description
Ease to identify the epidural space	30 minutes	Number of cases having required more than 2 punctures and number of failures of the technique

Secondary

Measure	Time frame	Description
Duration of epidural procedure	30 minutes	—
Number of cutaneous punctures	30 minutes	—
Number of needle redirections	30 minutes	—
Ease of epidural catheter insertion	30 minutes	—
Number of inadequate postoperative analgesia	one day after anesthesia	asymmetric, incomplete or failed analgesia

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026