Skip to main content
OpenTrials
Completed

NCT Number: NCT04759547

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Labor Analgesia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

handheld ultrasound-assisted technique

Device

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

conventional palpation-guided technique

Other

The interspinous space is detected by palpation

Primary outcomes

  1. 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 outcomes

  1. Number of passes

    Time frame: During procedure

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

  2. Number of needle insertion attempts

    Time frame: During procedure

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

  3. 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

  4. Identifying time

    Time frame: During procedure

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

  5. Success rate at the first needle pass

    Time frame: During procedure

    Success rate at the first needle pass

  6. Success rate at the first attempt

    Time frame: During procedure

    Success rate at the first attempt

  7. Need to use alternative methods

    Time frame: During procedure

    Need to use alternative methods for success

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

    Time frame: During procedure

    Number of interspace levels at which the insertion was attempted

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

    Time frame: During procedure

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

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

    Time frame: During procedure

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

  11. 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)

  12. 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)

  13. Depth by ultrasound

    Time frame: During procedure

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

  14. Actual needle depth (cm)

    Time frame: During procedure

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

  15. 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

  16. 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)

  17. Incidence of inadvertent dural puncture

    Time frame: During procedure

    Incidence of inadvertent dural puncture

  18. Incidence of postdural puncture headache

    Time frame: Up to 2 weeks

    Incidence of postdural puncture headache

  19. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2021
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.