NCT01597466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

May 5, 2012

Last Update Submit

November 2, 2016

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Ease to identify the epidural space

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

    30 minutes

Secondary Outcomes (5)

  • 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

Study Arms (2)

Epidrum

EXPERIMENTAL

Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)

Device: Epidural catheter placement

Loss of resistance technique

ACTIVE COMPARATOR
Procedure: Epidural catheter placement

Interventions

Epidural catheter placementDEVICE

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

Epidrum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective major thoracic surgery requiring thoracic epidural analgesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Marseille

Marseille, 13915, France

Location

Hopital Foch

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Morgan Le Guen, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

  • Marc Fischler, MD

    Hopital Foch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2012

First Posted

May 14, 2012

Study Start

April 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

FR(2)