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

Seoul National University

Status: Completed

Conditions: Labor Analgesia

Treatments: Other: conventional palpation-guided technique; Device: handheld ultrasound-assisted technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04759547

2101-016-1186

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

84 participants in 2 patient groups

Handheld ultrasound-assisted technique

Experimental group

Description:

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

Treatment:

Device: handheld ultrasound-assisted technique

Conventional palpation-guided technique

Active Comparator group

Description:

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

Treatment:

Other: conventional palpation-guided technique