Handheld Ultrasound-assisted Versus Palpation-guided Labor Combined Spinal-epidural Analgesia

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ClinicalTrials.gov Identifier: NCT04759547

Recruitment Status : Recruiting

First Posted : February 18, 2021

Last Update Posted : March 19, 2021

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Sponsor:

Information provided by (Responsible Party):

Sun-Kyung Park, Seoul National University Hospital

Study Description

Brief Summary:

Parturients who need combined spinal-epidural analgesia for labour analgesia are randomly assigned to two groups. For the handheld ultrasound-assisted technique group, ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle. For the conventional palpation-guided technique group, the interspinous space is detected by palpation. Procedure time, the number of needle passes, the number of needle insertion attempts, success rate, and complications are compared.

Condition or disease	Intervention/treatment	Phase
Labor Analgesia	Device: handheld ultrasound-assisted technique Other: conventional palpation-guided technique	Not Applicable

Detailed Description:

This study aims to determine whether handheld ultrasound-guidance can reduce procedural time for labor combined spinal-epidural analgesia compared with conventional surface landmark-guided technique.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	84 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Handheld Ultrasound-assisted Versus Palpation-guided Labor Combined Spinal-epidural Analgesia: a Randomized Controlled Trial
Actual Study Start Date :	March 5, 2021
Estimated Primary Completion Date :	March 5, 2022
Estimated Study Completion Date :	April 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Non-Drug Pain Management

Genetic and Rare Diseases Information Center resources: Agnosia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Handheld ultrasound-assisted technique Participants will be received labor combined epidural-spinal analgesia using handheld ultrasound	Device: handheld ultrasound-assisted technique Ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle.
Active Comparator: Conventional palpation-guided technique Participants will be received labor combined epidural-spinal analgesia using conventional landmark-guided technique	Other: conventional palpation-guided technique The interspinous space is detected by palpation

Outcome Measures

Primary Outcome Measures :

Total duration of combined spinal-epidural procedure [ Time Frame: During procedure ]
Identifying time (time required to complete the preprocedural spinal ultrasound or the assessment by palpation) + Procedural duration (time from the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter)

Secondary Outcome Measures :

Number of passes [ Time Frame: During procedure ]
Number of times the puncture needle was redirected without removing it from the skin
Number of needle insertion attempts [ Time Frame: During procedure ]
Number of times the puncture needle was removed from the skin and reinserted
Procedural duration [ Time Frame: During procedure ]
time from the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter
Identifying time [ Time Frame: During procedure ]
time required to complete the preprocedural spinal ultrasound or the assessment by palpation
Success rate at the first needle pass [ Time Frame: During procedure ]
Success rate at the first needle pass
Success rate at the first attempt [ Time Frame: During procedure ]
Success rate at the first attempt
Need to use alternative methods [ Time Frame: During procedure ]
Need to use alternative methods for success
Number of interspace levels at which the insertion was attempted [ Time Frame: During procedure ]
Number of interspace levels at which the insertion was attempted
Success rate of dural puncture with needle-through-needle technique [ Time Frame: During procedure ]
Success rate of dural puncture with needle-through-needle technique
Incidence of radicular pain, paresthesia, and bloody tapping [ Time Frame: During procedure ]
Incidence of radicular pain, paresthesia, and bloody tapping during the procedure
Procedural pain using 11-point verbal rating scale [ Time Frame: During procedure ]
Degree of pain during the procedure using 11-point verbal rating scale (0=no pain, 10=most pain imaginable)
Procedural discomfort using 11-point verbal rating scale [ Time Frame: During procedure ]
Degree of discomfort during the procedure using 11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)
Depth by ultrasound [ Time Frame: During procedure ]
Depth to the ligamentum flavum-dura mater complex (LFD) as determined by ultrasound
Actual needle depth (cm) [ Time Frame: During procedure ]
Depth of the needle when the epidural space and dural space are found (cm)
Failure of labor analgesia [ Time Frame: Within 2 hours after the procedure ]
The need to reinsert a new epidural catheter due to lack of sufficient analgesia within 2 hours of the primary insertion
Patient satisfaction using 11-point verbal rating scale [ Time Frame: From the end of the procedure to delivery ]
Patient satisfaction with the quality of labor analgesia using 11-point verbal rating scale (0=very unsatisfied, 10=very satisfied)
Incidence of inadvertent dural puncture [ Time Frame: During procedure ]
Incidence of inadvertent dural puncture
Incidence of postdural puncture headache [ Time Frame: Up to 2 weeks ]
Incidence of postdural puncture headache
Incidence of back pain postpartum at the site of epidural insertion [ Time Frame: Up to 2 weeks ]
Incidence of back pain postpartum at the site of epidural insertion

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

- Adult parturients with ASA physical status classification I, II or III requiring a combined spinal-epidural for labor analgesia

Exclusion Criteria:

Contraindication to neuraxial anesthesia (local anesthetics hypersensitivity, coagulopathy, needle insertion site infection, etc.)
Difficulty in communication
Severe cardiac disease
History of spine surgery
Anatomical abnormality of the lumbar spine
Age under 18

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759547

Contacts

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Contact: Jinyoung Bae, M.D.	82-2072-2467	baejy88@gmail.com
Contact: Sun-Kyung Park, M.D.	82-2072-3283	mayskpark@gmail.com

Locations

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Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 03080
Contact: Sun-Kyung Park, MD, PhD mayskpark@gmail.com

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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Principal Investigator:	Sun-Kyung Park, M.D.	Seoul National University Hospital

More Information

Publications:

Simmons SW, Taghizadeh N, Dennis AT, Hughes D, Cyna AM. Combined spinal-epidural versus epidural analgesia in labour. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003401. doi: 10.1002/14651858.CD003401.pub3. Review.

Neal JM, Brull R, Horn JL, Liu SS, McCartney CJ, Perlas A, Salinas FV, Tsui BC. The Second American Society of Regional Anesthesia and Pain Medicine Evidence-Based Medicine Assessment of Ultrasound-Guided Regional Anesthesia: Executive Summary. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):181-94. doi: 10.1097/AAP.0000000000000331. Review.

Perlas A, Chaparro LE, Chin KJ. Lumbar Neuraxial Ultrasound for Spinal and Epidural Anesthesia: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):251-60. doi: 10.1097/AAP.0000000000000184. Review.

Yoo S, Kim Y, Park SK, Ji SH, Kim JT. Ultrasonography for lumbar neuraxial block. Anesth Pain Med (Seoul). 2020 Oct 30;15(4):397-408. doi: 10.17085/apm.20065. Review.

Park SK, Bae J, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-Assisted Versus Landmark-Guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy: A Randomized Controlled Trial. Anesth Analg. 2020 Mar;130(3):787-795. doi: 10.1213/ANE.0000000000004600.

Park SK, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):763-771. doi: 10.1097/EJA.0000000000001029.

Bae J, Park SK, Yoo S, Lim YJ, Kim JT. Influence of age, laterality, patient position, and spinal level on the interlamina space for spinal puncture. Reg Anesth Pain Med. 2019 Nov 4. pii: rapm-2019-100980. doi: 10.1136/rapm-2019-100980. [Epub ahead of print]

Tawfik MM, Atallah MM, Elkharboutly WS, Allakkany NS, Abdelkhalek M. Does Preprocedural Ultrasound Increase the First-Pass Success Rate of Epidural Catheterization Before Cesarean Delivery? A Randomized Controlled Trial. Anesth Analg. 2017 Mar;124(3):851-856. doi: 10.1213/ANE.0000000000001325.

Chin A, Crooke B, Heywood L, Brijball R, Pelecanos AM, Abeypala W. A randomised controlled trial comparing needle movements during combined spinal-epidural anaesthesia with and without ultrasound assistance. Anaesthesia. 2018 Apr;73(4):466-473. doi: 10.1111/anae.14206. Epub 2018 Jan 10.

Arzola C, Mikhael R, Margarido C, Carvalho JC. Spinal ultrasound versus palpation for epidural catheter insertion in labour: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jul;32(7):499-505. doi: 10.1097/EJA.0000000000000119.

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Responsible Party:	Sun-Kyung Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT04759547
Other Study ID Numbers:	2101-016-1186
First Posted:	February 18, 2021 Key Record Dates
Last Update Posted:	March 19, 2021
Last Verified:	March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Agnosia Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases

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