NCT03805958

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

January 13, 2019

Last Update Submit

September 20, 2019

Conditions

Regional Anesthesia MorbidityUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Number of needle pass

    Number of needle pass

    intraoperative

Study Arms (2)

Pre-procedure

EXPERIMENTAL

Confirmed landmark by ultrasound scan before procedure

Procedure: prescan ultrasonography

Real time

ACTIVE COMPARATOR

Confirmed landmark by ultrasound scan during procedure

Procedure: realtime ultrasonography

Interventions

realtime ultrasonographyPROCEDURE

Applying realtime ultrasound during the combined anesthesia

Real time
prescan ultrasonographyPROCEDURE

Applying realtime ultrasound before the combined anesthesia

Pre-procedure

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal/Epidural combined anesthesia is required.

You may not qualify if:

  • Skin infection or trauma
  • Abnormal coagulation lab
  • History of spine surgery
  • Pregnancy
  • Abnormal structure of spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

    PMID: 11172514BACKGROUND

  • 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.

    PMID: 17350519BACKGROUND

Study Officials

  • Tae Kyong Kim, Kim

    SMG-SNU Boramae hospital

    STUDY DIRECTOR

Central Study Contacts

Tae Kyong Kim, MD, phD

CONTACT

+82-2-870-2519ktkktk@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 13, 2019

First Posted

January 16, 2019

Study Start

November 15, 2019

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share