Tokyo, June 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061871) titled 'Study of pre-procedure learning with 3D CT images before epidural anesthesia for surgery' on June 11.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Institute of Science Tokyo Hospital

Condition: Condition - Surgical patients scheduled to undergo epidural anesthesia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to clarify the effect of reviewing spinal anatomical information obtained from three-dimensional reconstruction of preoperative CT images before performing epidural anesthesia on the procedure time required for epidural catheter insertion, the number of puncture attempts, and puncture-related adverse events.

Preoperative assessment using three-dimensional reconstructed CT images has increasingly been applied in clinical practice in recent years; however, prospective studies evaluating its usefulness remain limited. This study is expected to provide findings that may contribute to improving the safety and efficiency of epidural anesthesia procedures. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Pre-procedure learning using 3D reconstructed CT images (intervention group only): Before performing epidural anesthesia, the anesthesiologist responsible for the procedure reviews the three-dimensional reconstructed CT images and evaluates or simulates the following items:

Determination of the target intervertebral level Width and angle of the intervertebral space Simulation of the inclination of the spinous processes and the needle insertion angle Measurement of the estimated distance from the skin to the epidural space Identification of potentially difficult puncture sites due to degenerative changes, such as osteophytes Interventions/Control_2 - Control group: In the control group, the three-dimensional reconstructed CT images prepared for this study are not reviewed before the procedure. However, standard preoperative information required for routine clinical practice, such as plain radiographs and two-dimensional CT images, may be reviewed.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Key inclusion criteria

Patients scheduled to undergo surgery with epidural anesthesia at Tokyo Medical and Dental University Hospital / Institute of Science Tokyo Hospital. Patients who have already undergone preoperative CT imaging including the spinal region, regardless of whether contrast-enhanced or non-contrast CT was performed. Patients who provide written informed consent for participation in this study or for the use of their clinical data. Patients aged 20 years or older at the time of consent. Both male and female patients are eligible. Epidural anesthesia will be performed by a senior resident in anesthesiology who has not yet obtained certification as an anesthesiology practitioner and who has provided consent to participate in this study. The supervising anesthesiologist must be a board-certified anesthesiologist or higher, be familiar with the simulation method using SYNAPSE VINCENT, and have provided consent to participate in this study. Key exclusion criteria - Key exclusion criteria

Patients in whom standard epidural anesthesia is considered difficult or not indicated for medical reasons. Patients with absolute contraindications to epidural anesthesia, such as infection at the puncture site, coagulation abnormalities, or thrombocytopenia. Patients who do not provide consent to participate in the study or who withdraw consent. Patients who are unable to maintain the required position for epidural anesthesia. Patients with significant preoperative neurological symptoms. Patients undergoing emergency surgery for whom there is insufficient time to perform pre-procedure simulation using three-dimensional reconstructed CT images. Pregnant patients. Patients deemed unsuitable for participation in this study by the principal investigator or a sub-investigator. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 28 Day Date of IRB - 2026 Year 04 Month 28 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070751

Disclaimer: Curated by HT Syndication.