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

Handheld Ultrasound-assisted Versus Palpation-guided Labor Combined Spinal-epidural Analgesia: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Labor Analgesia
• Intervention / Treatment: Device: handheld ultrasound-assisted technique; Other: conventional palpation-guided technique

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total duration of combined spinal-epidural 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)	During procedure

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General 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(10):CD003401. doi: 10.1002/14651858.CD003401.pub3.
• 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.
• 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.
• 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.
• 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:rapm-2019-100980. doi: 10.1136/rapm-2019-100980. Online 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): December 23, 2021
• Study Completion (Actual): December 25, 2021

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: 2101-016-1186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No