"Elena Venizelou" General and Maternity Hospital of Athens
Athens, Attica, 11521, Greece
NCT Number: NCT05798754
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.
Trial opening soon.
Get Notified18 year–80 year
Female
Interventional
Not applicable
Athens, Attica, 11521, Greece
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
The thoracic epidural space will be identified by the loss of resistance (LOR) technique
The thoracic epidural space will be identified by the CompuFlo® technology
Time frame: Loss of sensation to cold 20 min after the first dose administered through the epidural catheter
The success of the thoracic epidural space identification
Time frame: Loss of sensation to cold 20 min after the first dose administered through the epidural catheter during the first attempt
Percentage of successful thoracic epidural space identification by the first attempt
Time frame: 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
Number of attempts to successful thoracic epidural space identification
Time frame: Time to insertion of epidural needle (Tuohy) in the supraspinous ligament to insertion of the epidural catheter
Time to identify the thoracic epidural space
Time frame: From epidural needle insertion up to 72 hours postoperatively
Adverse events (dural puncture, epidural hematoma, neurological deficit)
Contact information is provided by the study sponsor or research team.
General and Maternity Hospital of Athens Elena Venizelou
Other
Correlation of Standard Loss of Resistance Technique Versus the CompuFlo®-Assisted Technology for Thoracic Epidural Space Identification
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