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Completed

NCT Number: NCT01597466

Epidrum for Thoracic Epidural Analgesia

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Marseille, Marseille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epidural catheter placement

Device

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

Epidural catheter placement

Procedure

Epidural space is located using loss of resistance technique (saline solution)

Primary outcomes

  1. Ease to identify the epidural space

    Time frame: 30 minutes

    Number of cases having required more than 2 punctures and number of failures of the technique

Secondary outcomes

  1. Duration of epidural procedure

    Time frame: 30 minutes

  2. Number of cutaneous punctures

    Time frame: 30 minutes

  3. Number of needle redirections

    Time frame: 30 minutes

  4. Ease of epidural catheter insertion

    Time frame: 30 minutes

  5. Number of inadequate postoperative analgesia

    Time frame: one day after anesthesia

    asymmetric, incomplete or failed analgesia

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: Epidrum-Tho

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 14, 2012
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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