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

NCT06241716 | Recruiting

• 1 other identifier: 102114
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Ultrasound Therapy; Complications

Outcome Measures

Primary Outcomes (1)

• First puncture success rate

  The proportion of the first successful puncture to the total successful puncture

  1 year

Secondary Outcomes (7)

• Procedure time

  1 year

• Positioning time

  1 year

• Depth and width of posterior dural complex

  1 year

• Skin puncture times

  1 year

• Number of redirects

  1 year

Study Arms (2)

Ultrasound-assisted localization, US-AS

ACTIVE COMPARATOR

Procedure: Ultrasound-assisted localization, US-AS; Procedure: Real-time ultrasound guidance, US-RTG

Real-time ultrasound guidance, US-RTG

EXPERIMENTAL

Procedure: Ultrasound-assisted localization, US-AS; Procedure: Real-time ultrasound guidance, US-RTG

Interventions

Ultrasound-assisted localization, US-AS PROCEDURE

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; Ultrasound-assisted localization, US-AS

Real-time ultrasound guidance, US-RTG PROCEDURE

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.

Real-time ultrasound guidance, US-RTG; Ultrasound-assisted localization, US-AS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tianzhu Liu

Wuhan, Hubei, 430000, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 5, 2024
• Study Start: February 20, 2024
• Primary Completion: October 20, 2025
• Study Completion: January 20, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

CN (1)