Ultrasound-assisted Thoracic Epidural Catheter Insertion

Abdominal Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890640
• Other study ID #: 2019-0320
• Status: Completed
• Phase: N/A
• Start date: July 4, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 20, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Neoplasm
• Abdominal Neoplasms
• Neoplasms
• Thoracic Neoplasm
• Thoracic Neoplasms

Intervention

Procedure:
• Ultrasound-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.

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of ultrasound-guided thoracic epidural catheter insertion	Confirmation success of ultrasound-guided thoracic epidural catheter insertion using fluoroscopic images; success means that the catheter tip is located in the epidural space.	on the day of the procedure
Secondary	Number of skin punctures	complete needle withdrawal from the skin and reinsertion at a new location	on the day of the procedure
Secondary	Number of needle passes	First 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)	on the day of the procedure
Secondary	First attempt success rate	only first needle pass and first skin puncture	on the day of the procedure