Ultrasound-assisted Versus Real-time Ultrasound-guided Combined Spinal-epidural Anesthesia in Elderly Patients

Not Applicable

Recruiting

• Conditions: Ultrasound Therapy; Complications
• Interventions: Procedure: Ultrasound-assisted localization, US-AS; Procedure: Real-time ultrasound guidance, US-RTG

• Registration Number: NCT06241716
• Lead Sponsor: Tongji Hospital

Brief Summary

This study aims to compare the clinical effects of ultrasound-assisted localization and real-time ultrasound-guided combined spinal-epidural anesthesia via paramedian approach in elderly patients

Detailed Description

This study aims to compare the clinical effects of ultrasound-assisted localization and real-time ultrasound-guided combined spinal-epidural anesthesia via paramedian approach in elderly patients

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-05
• Study Start: 2024-02-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-10-20
• Study Completion: 2026-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Elderly patients (≥ 60 years old);
• ASA Grade I to III.

Exclusion Criteria

• Severe obesity (BMI>35kg/m2);
• Spinal deformity or surgical history;
• Allergic to local anesthetics;
• There are coagulation disorders;
• Communication barriers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-assisted localization, US-AS	Ultrasound-assisted localization, US-AS	-
Ultrasound-assisted localization, US-AS	Real-time ultrasound guidance, US-RTG	-
Real-time ultrasound guidance, US-RTG	Real-time ultrasound guidance, US-RTG	-
Real-time ultrasound guidance, US-RTG	Ultrasound-assisted localization, US-AS	-

Primary Outcome Measures

Name	Time	Method
First puncture success rate	1 year	The proportion of the first successful puncture to the total successful puncture

Secondary Outcome Measures

Name	Time	Method
Positioning time	1 year	The time required for pre-scanning and positioning (In seconds).
Procedure time	1 year	The time from the contact of the ultrasonic probe to the end of the operation (In seconds).
Depth and width of posterior dural complex	1 year	Obtained by ultrasonic measurement (In centimetres).
Skin puncture times	1 year	Count the number of skin piercings (In seconds).
Number of redirects	1 year	Count the number of needle redirection
Patient satisfaction score (How satisfied the patient is with the whole procedure)	1 year	1 is very dissatisfied; 2 is not satisfied; 3 is generally satisfied; 4 are relatively satisfied; A score of 5 is very satisfactory
Operator satisfaction score (How satisfied the patient is with the whole procedure)	1 year	1 is very dissatisfied; 2 is not satisfied; 3 is generally satisfied; 4 are relatively satisfied; A score of 5 is very satisfactory

Trial Locations

Locations (1)

Tianzhu Liu; 🇨🇳 Wuhan, Hubei, China