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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00083-40 | Other Identifier | ANSM |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidrum | Experimental | Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.) |
|
| Loss of resistance technique | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural catheter placement | Device | Epidural space is located using Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ease to identify the epidural space | Number of cases having required more than 2 punctures and number of failures of the technique | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of epidural procedure | 30 minutes | |
| Number of cutaneous punctures | 30 minutes | |
| Number of needle redirections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morgan Le Guen, MD | Hopital Foch | Principal Investigator |
| Marc Fischler, MD | Hopital Foch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Marseille | Marseille | 13915 | France | |||
| Hopital Foch |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Epidural catheter placement | Procedure | Epidural space is located using loss of resistance technique (saline solution) |
|
| 30 minutes |
| Ease of epidural catheter insertion | 30 minutes |
| Number of inadequate postoperative analgesia | asymmetric, incomplete or failed analgesia | one day after anesthesia |
| Suresnes |
| 92151 |
| France |