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

NCT04001387 | Unknown DMC

• 1 other identifier: 20-2019-32
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Regional Anesthesia Morbidity

Outcome Measures

Primary Outcomes (1)

• Successful perfomance of spinal anesthesia

  Rate of successful performance of real-time ultrasound guided spinal needle insertion using dynamic needle tip positioning

  Assessed at time of spinal anesthetic injection (baseline)

Study Arms (1)

Spinal anesthesia

Procedure: Real-time ultrasound guided spinal anesthesia

Interventions

Real-time ultrasound guided spinal anesthesia 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.

Spinal anesthesia

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who scheduled for elective surgery under spinal anesthesia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (8)

• 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: 11172514 BACKGROUND

• 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: 17350519 BACKGROUND

• 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.

  PMID: 18319185 BACKGROUND

• 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.

  PMID: 14768920 BACKGROUND

• 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.

  PMID: 28983903 BACKGROUND

• 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.

  PMID: 29135593 BACKGROUND

• 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.

  PMID: 29787409 BACKGROUND

• 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.

  PMID: 30638922 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: October 27, 2019
• Primary Completion: May 26, 2020
• Study Completion: June 26, 2020
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)