Thoracic Epidural Space Identification
Conditions
Keywords
thoracic, epidural space, loss of resistance technique, CompuFlo® technology
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURELoss of resistance (LOR) technique
The thoracic epidural space will be identified by the loss of resistance (LOR) technique
DEVICECompuFlo® technology
The thoracic epidural space will be identified by the CompuFlo® technology
Sponsors
General and Maternity Hospital of Athens Elena Venizelou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Member of the study group that assesses the epidural's success
Intervention model description
Prospective blind, non-inferiority randomized trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of successful thoracic epidural space identification | Loss of sensation to cold 20 min after the first dose administered through the epidural catheter | The success of the thoracic epidural space identification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Percentage of successful thoracic epidural space identification by the first attempt |
| 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 | Number of attempts to successful thoracic epidural space identification |
| Time to identify the thoracic epidural space | Time to insertion of epidural needle (Tuohy) in the supraspinous ligament to insertion of the epidural catheter | Time to identify the thoracic epidural space |
| Adverse events | From epidural needle insertion up to 72 hours postoperatively | Adverse events (dural puncture, epidural hematoma, neurological deficit) |
Countries
Greece
Contacts
CONTACTGeorgia Micha, Assistant Professor
CONTACTMohamed Abdullah, MD
STUDY_DIRECTORKonstantinos Stroumpoulis, PhD
General and Maternity Hospital of Athens Helena Venizelou
Outcome results
None listed