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The aim of this non inferiority trial is to assess the efficacy of CompuFlo® technology to identify the thoracic epidural space in relation to the gold standard loss of resistance technique.
This non inferiority trial shouts to adress whether the CompuFlo® technology to identify the thoracic epidural space is less efficacious to the gold standard loss of resistance technique (LOR). After informed signed consent patients that will be subjected to gynecological operations and meet the inclusion criteria will be eligible to participate. All operations will be performed under general anesthesia and thoracic epidural analgesia regardless of study arm. Patients will be randomly allocated into two study groups. In the first study group (Group LOR) the thoracic epidural space will be identified by the LOR technique and in the second study group (Group C) by the CompuFlo® technology. The primary outcome is the percentage of thoracic epidural space identification success in either study group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group LOR | Active Comparator | The thoracic epidural space will be identified by the loss of resistance technique. |
|
| Group C | Active Comparator | The thoracic epidural space will be identified by the CompuFlo® technology. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loss of resistance (LOR) technique | Procedure | The thoracic epidural space will be identified by the loss of resistance (LOR) technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of successful thoracic epidural space identification | The success of the thoracic epidural space identification | Loss of sensation to cold 20 min after the first dose administered through the epidural catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of successful thoracic epidural space identification by the first attempt | Percentage of successful thoracic epidural space identification by the first attempt | Loss of sensation to cold 20 min after the first dose administered through the epidural catheter during the first attempt |
| Number of attempts to successful thoracic epidural space identification |
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Inclusion Criteria:
American Society of Anesthesiologists (ASA) Physical Status Classification System I-III Body mass index: 18 -35 kg/m2 Gynecological laparotomy with midline incision under general anesthesia and thoracic epidural analgesia
Exclusion Criteria:
Patients' denial to participate in the study ASA Physical Status Classification System >IV Contraindications to epidural analgesia Patients with sepsis Patients with pre-existing neurologic deficits Pre-existing operations in the thoracic spinal cord Emergency operations Patients with end-stage cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgia Micha, Assistant Professor | Contact | +306974828254 | michageorgia@uoi.gr | |
| Mohamed Abdullah, MD | Contact | 00302132051000 | 2214 | mohammed12_90@yahoo.co.uk |
| Name | Affiliation | Role |
|---|---|---|
| Konstantinos Stroumpoulis, PhD | General and Maternity Hospital of Athens Helena Venizelou | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Elena Venizelou" General and Maternity Hospital of Athens | Athens | Attica | 11521 | Greece |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Prospective blind, non-inferiority randomized trial
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Member of the study group that assesses the epidural's success
| CompuFlo® technology | Device | The thoracic epidural space will be identified by the CompuFlo® technology |
|
Number of attempts to successful thoracic epidural space identification |
| Number of attempts to successful thoracic epidural space identification up to a maximum of 3 adressed as loss of sensation to cold 20 min after the first dose administered through the epidural catheter |
| Time to identify the thoracic epidural space | Time to identify the thoracic epidural space | Time to insertion of epidural needle (Tuohy) in the supraspinous ligament to insertion of the epidural catheter |
| Adverse events | Adverse events (dural puncture, epidural hematoma, neurological deficit) | From epidural needle insertion up to 72 hours postoperatively |