Ultrasound-assisted Thoracic Epidural Catheter Insertion

NCT ID: NCT03890640

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2019-12-20

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.

Conditions

Abdominal Neoplasm; Thoracic Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ultrasound-guided TECI

After assessment of the epidural space using the loss of resistance technique with saline under ultrasound guidance, fluoroscopic views will be obtained to confirm which the catheter tip is located in the epidural space or not.

Group Type: EXPERIMENTAL

Ultrasound-guided TECI

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jong Hyuk Lee

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jong-Hyuk Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan medical center

Seoul, , South Korea

Countries

South Korea

References

Kim DH, Lee JH, Sim JH, Jeong W, Lee D, Kwon HM, Choi SS, Jeong SM. Real-time ultrasound-guided low thoracic epidural catheter placement: technical consideration and fluoroscopic evaluation. Reg Anesth Pain Med. 2021 Jun;46(6):512-517. doi: 10.1136/rapm-2021-102578. Epub 2021 Apr 23.

Reference Type: DERIVED

PMID: 33893174 (View on PubMed)

Other Identifiers

2019-0320

Identifier Type: -

Identifier Source: org_study_id