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

NCT ID: NCT03805958

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2020-01-15

Brief 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.

Detailed 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.

Conditions

Regional Anesthesia Morbidity; Ultrasonography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Pre-procedure

Confirmed landmark by ultrasound scan before procedure

Group Type: EXPERIMENTAL

prescan ultrasonography

Intervention Type: PROCEDURE

Applying realtime ultrasound before the combined anesthesia

Real time

Confirmed landmark by ultrasound scan during procedure

Group Type: ACTIVE_COMPARATOR

realtime ultrasonography

Intervention Type: PROCEDURE

Applying realtime ultrasound during the combined anesthesia

Interventions

realtime ultrasonography

Applying realtime ultrasound during the combined anesthesia

Intervention Type: PROCEDURE

prescan ultrasonography

Applying realtime ultrasound before the combined anesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tae Kyong Kim

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tae Kyong Kim, Kim

Role: STUDY_DIRECTOR

SMG-SNU Boramae hospital

Central Contacts

Tae Kyong Kim, MD, phD

Role: CONTACT

ktkktk@gmail.com

+82-2-870-2519

References

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. doi: 10.1053/rapm.2001.19633. No abstract available.

Reference Type: BACKGROUND

PMID: 11172514 (View on PubMed)

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. doi: 10.1016/j.rapm.2006.10.005.

Reference Type: BACKGROUND

PMID: 17350519 (View on PubMed)

Other Identifiers

30-2018-81

Identifier Type: -

Identifier Source: org_study_id