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Comparison of real-time ultrasound and fluoroscopy for thoracic epidural catheter placement

Comparison of clinical utilities between real-time ultrasound- and fluoroscopy-assisted thoracic epidural catheter placement: A randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006521
Enrollment
132
Registered
2021-08-31
Start date
2021-10-05
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

None listed

Interventions

Procedure/Surgery : All patients are placed in the prone position with a pillow under the upper abdomen to widen the target interlaminar space. Routine monitoring is established prior to the procedure

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who undergo open thoracic or abdominal surgery 2) Patients who is required thoracic epidural catheter placement 3) 20 = age <80 4) Patients who want to participate in this study and write informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1) An allergy to local anesthetics and contrast dye 2) Patients who are contraindicated in nerve block such as coagulopathy, antiplatelet therapy, infection 3) Neurological or psychiatric disorders 4) Pregnancy 5) Patients who had surgery on the thoracic spine 6) Patients who had thoracic compression fracture 7) Patients who do not want to participate in this study

Design outcomes

Primary

MeasureTime frame
First attempt success: achievement of LOR and successful catheter placement on first needle pass and first skin puncture

Secondary

MeasureTime frame
immediate postoperative pain after surgery (assessed by a numeric rating scale (0 ~ 10)).;Time to mark spaces (seconds): the time to obtain the best ultrasound or fluoroscopic images of the target space, and mark the overlying skin;Needling time: time to access the epidural space after skin insertion;Total number of needle passes: first needle pass plus additional needle passes, that is, re-advancement of the needle after any needle withdrawal for changing the direction;Number of skin punctures: first skin puncture plus additional skin punctures, that is, reinsertion at a new location after complete needle withdrawal from the skin;Final success: achievement of LOR and successful catheter placement within allowed epidural access attempts per protocol, which should be confirmed by contrast dispersion in the epidural space / Failure: Failure of catheter placement within allowed epidural access attempts;Crossover trial success: achievement of LOR and successful catheter placement, using another group’s modality;Procedure related complications: intravascular or intrathecal local anesthetic injection, dural puncture, hematoma, cord injury, pneumothorax, vasovagal reaction;Location of epidural catheter tip;Dye spread (contrast dispersion);Skin to epidural distance (cm) ;Dermatomes;Procedural pain (assessed by a numeric rating scale (0 ~ 10));Patient satisfaction by global perceived effects on a 7-point scale (1 ~ 7)

Countries

Korea, Republic of

Contacts

Public ContactHyun-Jung Kwon

Asan Medical Center

hyunjung.kwon88@gmail.com+82-2-3010-2550

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 8, 2026