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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
276
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
"Elena Venizelou" General and Maternity Hospital of Athens
Athens, Attica, Greece
Percentage of successful thoracic epidural space identification
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
Percentage of successful thoracic epidural space identification by the first attempt
Percentage of successful thoracic epidural space identification by the first attempt
Time frame: 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
Number of attempts to successful thoracic epidural space identification
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
Time to identify the thoracic epidural space
Time to identify the thoracic epidural space
Time frame: 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)
Time frame: From epidural needle insertion up to 72 hours postoperatively
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