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Study of pre-procedure learning with 3D CT images before epidural anesthesia for surgery

Effect of learning support using three-dimensional reconstructed CT images for epidural anesthesia on catheter insertion time and adverse events: a single-center, prospective, randomized controlled interventional study - 3DCT-EA trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061871
Enrollment
100
Registered
2026-06-11
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical patients scheduled to undergo epidural anesthesia

Interventions

Pre-procedure learning using 3D reconstructed CT images (intervention group only): Before performing epidural anesthesia, the anesthesiologist responsible for the procedure reviews the three-dimensio

Sponsors

Institute of Science Tokyo Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Number of puncture attempts required for successful epidural puncture

Secondary

MeasureTime frame
Time from skin puncture to identification of the epidural space Proportion of cases requiring a change in the intervertebral puncture level Proportion of cases requiring a change in the operator performing the puncture Whether epidural catheter insertion was discontinued Incidence of accidental dural puncture Incidence of vascular puncture Incidence of epidural hematoma

Countries

Japan

Contacts

Public ContactShoko Imamura

Institute of Science Tokyo Hospital Anesthesiology

imamura.s.b07b@m.isct.ac.jp03-3813-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026