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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03805958
• Collaborator: (none)
• Enrollment: 56
• Arms: 2
• Anticipated Duration (Months): 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Regional Anesthesia Morbidity; Ultrasonography	Procedure: realtime ultrasonography; Procedure: prescan ultrasonography	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: A Randomized Comparison of the Ultrasound-guided Combined Spinal-epidural Anesthesia Technique: Pre-procedure Scan Versus Real-time Scan
• Anticipated Study Start Date: Nov 15, 2019
• Anticipated Primary Completion Date: Jan 15, 2020
• Anticipated Study Completion Date: Jan 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pre-procedure Confirmed landmark by ultrasound scan before procedure	Procedure: prescan ultrasonography; Applying realtime ultrasound before the combined anesthesia
Active Comparator: Real time Confirmed landmark by ultrasound scan during procedure	Procedure: realtime ultrasonography; Applying realtime ultrasound during the combined anesthesia

Outcome Measures

Primary Outcome Measures

1. Number of needle pass [intraoperative]

   Number of needle pass

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Study Director: Tae Kyong Kim, Kim, SMG-SNU Boramae hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Tae Kyong Kim, Assistant Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03805958
• Other Study ID Numbers: 30-2018-81
• First Posted: Jan 16, 2019
• Last Update Posted: Sep 23, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 23, 2019