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

Not Applicable

Completed

• Conditions: Labor Analgesia
• Interventions: Device: handheld ultrasound-assisted technique; Other: conventional palpation-guided technique

• Registration Number: NCT04759547
• Lead Sponsor: Seoul National University Hospital

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.

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 Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-18
• Study Start: 2021-03-05
• Primary Completion: 2021-12-23
• Study Completion: 2021-12-25
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Handheld ultrasound-assisted technique	handheld ultrasound-assisted technique	Participants will be received labor combined epidural-spinal analgesia using handheld ultrasound
Conventional palpation-guided technique	conventional palpation-guided technique	Participants will be received labor combined epidural-spinal analgesia using conventional landmark-guided technique

Primary Outcome Measures

Name	Time	Method
Total duration of combined spinal-epidural procedure	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 Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of