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

Seoul National University Hospital84 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Labor Analgesia

Interventions

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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)

Time frame: During procedure

Secondary Outcomes

Number of passes

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

Time frame: During procedure

Number of needle insertion attempts

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

Time frame: During procedure

Procedural duration

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

Time frame: During procedure

Identifying time

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

Time frame: During procedure

Success rate at the first needle pass

Time frame: During procedure

Success rate at the first attempt

Time frame: During procedure

Need to use alternative methods

Data from ClinicalTrials.gov

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