Ultrasound-guided Combined Spinal-epidural Anesthesia: Pre-procedure Versus Real-time Scan

Ultrasonography Clinical Trial

Official title:

A Randomized Comparison of the Ultrasound-guided Combined Spinal-epidural Anesthesia Technique: Pre-procedure Scan Versus Real-time Scan

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03805958
• Other study ID #: 30-2018-81
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: September 2019
• Source: Seoul National University Hospital
• Contact: Tae Kyong Kim, MD, phD
• Phone: +82-2-870-2519
• Email: ktkktk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction between 'Real-time scan' and 'Pre-procedure scan', when we performing spinal/epidural combined anesthesia.

Description:

Traditionally, spinal/epidural combined anesthesia has been performed by palpation of the landmark like Tuffier's line. There are some studies that using ultrasound improves the success rate to regional anesthesia. There are two methods of using ultrasonography, 'Real-time scan' and 'Pre-procedure scan'. Direct comparison of these two methods is not yet studied. So investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Spinal/Epidural combined anesthesia is required.

Exclusion Criteria:

• Skin infection or trauma

• Abnormal coagulation lab

• History of spine surgery

• Pregnancy

• Abnormal structure of spine

Related Conditions & MeSH terms

• Regional Anesthesia Morbidity
• Ultrasonography

Intervention

Procedure:
• realtime ultrasonography
Applying realtime ultrasound during the combined anesthesia
• prescan ultrasonography
Applying realtime ultrasound before the combined anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

References & Publications (2)

Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. — View Citation

Kil HK, Cho JE, Kim WO, Koo BN, Han SW, Kim JY. Prepuncture ultrasound-measured distance: an accurate reflection of epidural depth in infants and small children. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):102-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of needle pass	Number of needle pass	intraoperative