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

NCT04759547 | Completed DMC

• 1 other identifier: 2101-016-1186
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Number of passes

  During procedure

• Number of needle insertion attempts

  During procedure

• Procedural duration

  During procedure

• Identifying time

  During procedure

• Success rate at the first needle pass

  During procedure

Study Arms (2)

Handheld ultrasound-assisted technique

EXPERIMENTAL

Participants will be received labor combined epidural-spinal analgesia using handheld ultrasound

Device: handheld ultrasound-assisted technique

Conventional palpation-guided technique

ACTIVE COMPARATOR

Participants will be received labor combined epidural-spinal analgesia using conventional landmark-guided technique

Other: conventional palpation-guided technique

Interventions

handheld ultrasound-assisted technique DEVICE

Ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle.

Handheld ultrasound-assisted technique

conventional palpation-guided technique OTHER

The interspinous space is detected by palpation

Conventional palpation-guided technique

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (11)

• 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.

  PMID: 23076897 BACKGROUND

• 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.

  PMID: 26695878 BACKGROUND

• 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.

  PMID: 25493689 BACKGROUND

• 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.

  PMID: 33329842 BACKGROUND

• 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.

  PMID: 31880632 BACKGROUND

• 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.

  PMID: 31188153 BACKGROUND

• 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.

  PMID: 31690644 BACKGROUND

• 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.

  PMID: 27183373 BACKGROUND

• 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.

  PMID: 29322504 BACKGROUND

• 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.

  PMID: 25036283 BACKGROUND

• Bae J, Kim Y, Yoo S, Kim JT, Park SK. Handheld ultrasound-assisted versus palpation-guided combined spinal-epidural for labor analgesia: a randomized controlled trial. Sci Rep. 2023 Dec 27;13(1):23009. doi: 10.1038/s41598-023-50407-7.

  PMID: 38155223 DERIVED

Study Officials

• Sun-Kyung Park, M.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 18, 2021
• Study Start: March 5, 2021
• Primary Completion: December 23, 2021
• Study Completion: December 25, 2021
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)