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

Regional Anesthesia Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04001387
• Other study ID #: 20-2019-32
• Status: Not yet recruiting
• Start date: October 27, 2019
• Est. completion date: June 26, 2020

Study information

• Verified date: September 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 26, 2020
• Est. primary completion date: May 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Regional Anesthesia Morbidity

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)