PainEpidrum-ThoNCT01597466
Epidrum for Thoracic Epidural Analgesia
A study testing Epidural catheter placement in people with Pain, run by Hopital Foch at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Epidural catheter placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective major thoracic surgery requiring thoracic epidural analgesia
Who cannot join
- Contraindication to epidural anesthesia
- Marked spinal deformities or a history of spinal instrumentation
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Comparison Study of Two Different Techniques for Identifying the Epidural Space in Patients Requiring Thoracic Epidural Analgesia: a Prospective Multicentric Randomized Study
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.
- Conditions
- Pain
- Being tested
- Epidural catheter placement
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural catheter placementDevice
Epidural space is located using Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)
Epidural catheter placementProcedure or surgery
Epidural space is located using loss of resistance technique (saline solution)
| Study group | Role | What they receive |
|---|---|---|
| Epidrum | Experimental | Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.) Receives: Device: Epidural catheter placement |
| Loss of resistance technique | Active comparator | Not described Receives: Procedure: Epidural catheter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease to identify the epidural space
Number of cases having required more than 2 punctures and number of failures of the technique
Measured: 30 minutes
Secondary outcomes (5)
Duration of epidural procedure
Measured: 30 minutes
Number of cutaneous punctures
Measured: 30 minutes
Number of needle redirections
Measured: 30 minutes
Ease of epidural catheter insertion
Measured: 30 minutes
Number of inadequate postoperative analgesia
asymmetric, incomplete or failed analgesia
Measured: one day after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Le Guen, MD, Principal investigator, Hopital FochMarc Fischler, MD, Study chair, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597466
- Sponsor's protocol ID
- 2012/01
- Other IDs
- 2012-A00083-40
- Acronym
- Epidrum-Tho
- Status last verified
- Nov 2016
- First submitted
- 5 May 2012
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study of Two Different Techniques for Identifying the Epidural Space in Patients Requiring Thoracic Epidural Analgesia: a Prospective Multicentric Randomized Study
- ClinicalTrials.gov ID
- NCT01597466
- Acronym / sponsor ID
- Epidrum-Tho / 2012/01
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidrum | Experimental | Device: Epidural catheter placementEpidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.) |
| Loss of resistance technique | Active comparator | Procedure: Epidural catheter placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective major thoracic surgery requiring thoracic epidural analgesia
Key exclusion criteria (2 listed)
- Contraindication to epidural anesthesia
- Marked spinal deformities or a history of spinal instrumentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural catheter placementEpidural space is located using Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.) | Device | Epidrum |
| Epidural catheter placementEpidural space is located using loss of resistance technique (saline solution) | Procedure or surgery | Loss of resistance technique |
Primary outcome
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
5 secondary outcomes
Duration of epidural procedure
Time frame: 30 minutes
Number of cutaneous punctures
Time frame: 30 minutes
Number of needle redirections
Time frame: 30 minutes
Ease of epidural catheter insertion
Time frame: 30 minutes
Number of inadequate postoperative analgesia
Time frame: one day after anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan Le Guen, MD principal investigator
Hopital Foch
Marc Fischler, MD study chair
Hopital Foch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural catheter placement in people with Pain, run by Hopital Foch at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease to identify the epidural space (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.