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

Ultrasound Therapy; Complications Clinical Trial

Official title:

Ultrasound-assisted Versus Real-time Ultrasound-guided Combined Spinal-epidural Anesthesia Via a Paramedian Approach in Elderly Patients: a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241716
• Other study ID #: 102114
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: January 20, 2026

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: January 20, 2026
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ultrasound Therapy; Complications

Intervention

Procedure:
• Ultrasound-assisted localization, US-AS
In the US-AS group, ultrasonic prescan to determine the best intervertebral space, best puncture Angle and best puncture depth. The optimal puncture section considered by the operator was selected to record the best gap, puncture Angle and depth.
• Real-time ultrasound guidance, US-RTG
In the US-RTG group, the optimal puncture section considered by the operator was selected and recorded directly in the plane of the paracentral transverse section, out of the plane of the paracentral sagittal section or in the plane of the paracentral sagittal section for real-time ultrasound guided lumbar epidural anesthesia.

Locations

Country	Name	City	State
China	Tianzhu Liu	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

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