Feasibility of Real-time Ultrasound-guided Spinal Anesthesia Using Dynamic Needle Tip Positioning

NCT ID: NCT04001387

Last Updated: 2019-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-27

Study Completion Date

2020-06-26

Brief Summary

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Confirming the L4-L5 or L3-L4 vertebrae level with ultrasound in real time for adults who scheduled elective surgery under spinal anesthesia, and introduce the spinal needle into the subarachnoid space. The ultrasound probe continues to track needle tips in real time by sliding/tilting with short axis view. Check that the spinal needle reaches subarachnoid space, and that CSF is released through the needle hub, and administer the drug.

In this process, it is recorded by observing the success of the procedure, the time taken for each step, the number of needle position changes, NRS pain score of the subject, satisfaction with anesthesia, and its side effects.

Detailed Description

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Conditions

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Regional Anesthesia Morbidity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Spinal anesthesia

Real-time ultrasound guided spinal anesthesia

Intervention Type PROCEDURE

The neuraxial US scan will be performed with the patient in the lateral position with the hip and knees flexed using full aseptic technique. The spinal needle will be inserted in real-time under direct ultrasound guidance using dynamic needle tip positioning to administer the spinal anesthetic.

Interventions

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Real-time ultrasound guided spinal anesthesia

The neuraxial US scan will be performed with the patient in the lateral position with the hip and knees flexed using full aseptic technique. The spinal needle will be inserted in real-time under direct ultrasound guidance using dynamic needle tip positioning to administer the spinal anesthetic.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who scheduled for elective surgery under spinal anesthesia
* Age \>= 20

Exclusion Criteria

* Patient refusal
* Coagulopathy (INR ≥1.2, anticoagulant therapy)
* Sepsis or local infection at the site of injection
* BMI \> 35
* Spine deformity
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tae Kyong Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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)

Carvalho JC. Ultrasound-facilitated epidurals and spinals in obstetrics. Anesthesiol Clin. 2008 Mar;26(1):145-58, vii-viii. doi: 10.1016/j.anclin.2007.11.007.

Reference Type BACKGROUND
PMID: 18319185 (View on PubMed)

Grau T, Leipold RW, Fatehi S, Martin E, Motsch J. Real-time ultrasonic observation of combined spinal-epidural anaesthesia. Eur J Anaesthesiol. 2004 Jan;21(1):25-31. doi: 10.1017/s026502150400105x.

Reference Type BACKGROUND
PMID: 14768920 (View on PubMed)

Hanada S, Van Winkle MT, Subramani S, Ueda K. Dynamic ultrasound-guided short-axis needle tip navigation technique vs. landmark technique for difficult saphenous vein access in children: a randomised study. Anaesthesia. 2017 Dec;72(12):1508-1515. doi: 10.1111/anae.14082. Epub 2017 Oct 6.

Reference Type BACKGROUND
PMID: 28983903 (View on PubMed)

Kiberenge RK, Ueda K, Rosauer B. Ultrasound-Guided Dynamic Needle Tip Positioning Technique Versus Palpation Technique for Radial Arterial Cannulation in Adult Surgical Patients: A Randomized Controlled Trial. Anesth Analg. 2018 Jan;126(1):120-126. doi: 10.1213/ANE.0000000000002261.

Reference Type BACKGROUND
PMID: 29135593 (View on PubMed)

Liu L, Tan Y, Li S, Tian J. "Modified Dynamic Needle Tip Positioning" Short-Axis, Out-of-Plane, Ultrasound-Guided Radial Artery Cannulation in Neonates: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):178-183. doi: 10.1213/ANE.0000000000003445.

Reference Type BACKGROUND
PMID: 29787409 (View on PubMed)

Takeshita J, Yoshida T, Nakajima Y, Nakayama Y, Nishiyama K, Ito Y, Shimizu Y, Takeuchi M, Shime N. Dynamic Needle Tip Positioning for Ultrasound-Guided Arterial Catheterization in Infants and Small Children With Deep Arteries: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1919-1925. doi: 10.1053/j.jvca.2018.12.002. Epub 2018 Dec 4.

Reference Type BACKGROUND
PMID: 30638922 (View on PubMed)

Other Identifiers

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20-2019-32

Identifier Type: -

Identifier Source: org_study_id

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