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Labor AnalgesiaNCT04759547

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

A study testing handheld ultrasound-assisted technique and conventional palpation-guided technique in people with Labor Analgesia, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Labor Analgesia
What is being tested?
handheld ultrasound-assisted technique and conventional palpation-guided technique
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteSouth Korea
Study dates
5 Mar 2021to 25 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions
Labor Analgesia
Being tested
handheld ultrasound-assisted technique, conventional palpation-guided technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • handheld ultrasound-assisted techniqueDevice

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

  • conventional palpation-guided techniqueOther

    The interspinous space is detected by palpation

Study groups in NCT04759547
Study groupRoleWhat they receive
Handheld ultrasound-assisted techniqueExperimentalParticipants will be received labor combined epidural-spinal analgesia using handheld ultrasound
Receives: Device: handheld ultrasound-assisted technique
Conventional palpation-guided techniqueActive comparatorParticipants will be received labor combined epidural-spinal analgesia using conventional landmark-guided technique
Receives: Other: conventional palpation-guided technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: During procedure

Secondary outcomes (19)

  1. Number of passes

    Number of times the puncture needle was redirected without removing it from the skin

    Measured: During procedure

  2. Number of needle insertion attempts

    Number of times the puncture needle was removed from the skin and reinserted

    Measured: During procedure

  3. Procedural duration

    time from the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter

    Measured: During procedure

  4. Identifying time

    time required to complete the preprocedural spinal ultrasound or the assessment by palpation

    Measured: During procedure

  5. Success rate at the first needle pass

    Success rate at the first needle pass

    Measured: During procedure

  6. Success rate at the first attempt

    Success rate at the first attempt

    Measured: During procedure

  7. Need to use alternative methods

    Need to use alternative methods for success

    Measured: During procedure

  8. Number of interspace levels at which the insertion was attempted

    Number of interspace levels at which the insertion was attempted

    Measured: During procedure

  9. Success rate of dural puncture with needle-through-needle technique

    Success rate of dural puncture with needle-through-needle technique

    Measured: During procedure

  10. Incidence of radicular pain, paresthesia, and bloody tapping

    Incidence of radicular pain, paresthesia, and bloody tapping during the procedure

    Measured: During procedure

  11. 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)

    Measured: During procedure

  12. 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)

    Measured: During procedure

  13. Depth by ultrasound

    Depth to the ligamentum flavum-dura mater complex (LFD) as determined by ultrasound

    Measured: During procedure

  14. Actual needle depth (cm)

    Depth of the needle when the epidural space and dural space are found (cm)

    Measured: During procedure

  15. 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

    Measured: Within 2 hours after the procedure

  16. 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)

    Measured: From the end of the procedure to delivery

  17. Incidence of inadvertent dural puncture

    Incidence of inadvertent dural puncture

    Measured: During procedure

  18. Incidence of postdural puncture headache

    Incidence of postdural puncture headache

    Measured: Up to 2 weeks

  19. Incidence of back pain postpartum at the site of epidural insertion

    Incidence of back pain postpartum at the site of epidural insertion

    Measured: Up to 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2021
  2. Study start5 Mar 2021
  3. Primary completion23 Dec 2021
  4. Study completion25 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04759547
Sponsor's protocol ID
2101-016-1186
Status last verified
Oct 2022
First submitted
8 Feb 2021
Last updated
26 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 23076897

  • 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.

    PubMed 26695878

  • 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.

    PubMed 25493689

  • 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.

    PubMed 33329842

  • 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.

    PubMed 31880632

  • 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.

    PubMed 31188153

  • 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.

    PubMed 31690644

  • 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.

    PubMed 27183373

  • 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.

    PubMed 29322504

  • 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.

    PubMed 25036283

  • 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.

    PubMed 38155223

Questions about this trial

What is this clinical trial studying?

A study testing handheld ultrasound-assisted technique and conventional palpation-guided technique in people with Labor Analgesia, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total duration of combined spinal-epidural procedure (time frame: During procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04759547, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.

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