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Ultrasound-assisted Thoracic Epidural Catheter Insertion

Evaluation of the Accuracy of Real-time Ultrasound-assisted Thoracic Epidural Catheter Insertion: a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03890640
Enrollment
38
Registered
2019-03-26
Start date
2019-07-04
Completion date
2019-12-20
Last updated
2020-01-18

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

Conditions

Abdominal Neoplasm, Thoracic Neoplasm

Keywords

Ultrasound, Thoracic epidural catheter insertion, Fluoroscopy

Brief summary

The aim of the present study is to access the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy.

Detailed description

Thoracic epidural anesthesia has been associated with reduced acute postoperative pain for a wide variety of surgical procedures. It has also been associated with reductions in perioperative cardiac stress, chronic post-thoracotomy pain, and improvements in postoperative pulmonary function. Although a variety of methods can be used to confirm the position of the epidural needle in the epidural space, a blind technique and fluoroscopic guided approach are a widely used method. A thoracic epidural block is a relatively more difficult procedure than procedures used in other regions, because the spinous process of the thoracic vertebra is longer than that of the lumbar vertebra, and the area through which the needle can approach the epidural space is relatively smaller due to an acute angle and larger distance between the skin and the epidural space. Therefore, the success rate of thoracic epidural intervention is only about 68% under a blind technique due to inadequate position of the needle tip, misplacement, occlusion, and migration of the catheter. Although fluoroscopic guided thoracic epidural intervention is the safest and most accurate method to identify the correct anatomical structures and confirm the epidural space with contrast medium, its use is limited because of the difficulty of using fluoroscope and the burden of radiation exposure. As the use of ultrasound has become popularized and universal, it has been widely used in regional anesthesia and analgesia, has continuously replaced the modality such as a blind technique and fluoroscopic guidance. Ultrasound-guided thoracic epidural catheter insertion was also recently investigated, and then it was conducted successfully in 15 cases of thoracic and upper abdominal surgery. Moreover, it showed several advantages including lowering the number of needle passes and increasing the success rate. However, it has not yet been studied how accurately the catheter is located in the thoracic epidural space during thoracic epidural catheter insertion using real-time ultrasound. Although it is possible to speculate the success of the thoracic epidural catheterization clinically, the identification of the location of the catheter is only possible under fluoroscopic guidance. Therefore, in the present study, we aimed to confirm the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy with contrast medium.

Interventions

PROCEDUREUltrasound-guided TECI

When performing an ultrasound-guided thoracic epidural catheter insertion (TECI), an 18-gauge Tuohy needle will be used for interlaminar epidural access. All procedures will be performed with a paramedian approach under ultrasound-guidance and using the loss of resistance technique with saline. If the needle is deemed to be in the epidural space when the loss of resistance occurred, fluoroscopic views will be obtained to confirm which the catheter tip is located in the epidural space or not.

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

* Patients who will undergo upper abdomen or thoracic surgery * Scheduled for thoracic epidural catheter insertion * 20 ≤ age \<80 * When obtaining informed consent voluntarily

Exclusion criteria

* Allergy to local anesthetics and contrast dye, and steroid * Use of anticoagulants or antiplatelet medication, coagulopathy * Infection at the insertion site * Neurological or psychiatric disorders * Prior spine instrumentation * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Success rate of ultrasound-guided thoracic epidural catheter insertionon the day of the procedureConfirmation success of ultrasound-guided thoracic epidural catheter insertion using fluoroscopic images; success means that the catheter tip is located in the epidural space.

Secondary

MeasureTime frameDescription
Number of skin punctureson the day of the procedurecomplete needle withdrawal from the skin and reinsertion at a new location
Number of needle passeson the day of the procedureFirst needle pass + additional needle passes (the needle returned to a plane perpendicular to the skin before reinsertion. Needle tip maneuvers toward the midline and cephalad were considered standard needle walking technique and were counted as a single pass)
First attempt success rateon the day of the procedureonly first needle pass and first skin puncture

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026