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

NCT06241716 | Completed

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

Brief Summary

This prospective randomized controlled trial aims to compare the clinical efficacy and safety of real-time ultrasound guidance (US-RTG) versus static ultrasound-assisted mapping (US-AS) for combined spinal-epidural anesthesia (CSEA) via the paramedian approach in elderly patients aged 60 years and older undergoing orthopedic surgery.

Conditions

Ultrasound Therapy; Complications

Outcome Measures

Primary Outcomes (1)

• First-attempt success

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

  1 year

Secondary Outcomes (9)

• Operating time

  1 year

• Location time

  1 year

• Depth and width of posterior dural complex (DPEC, WPEC)

  1 year

• Number of skin punctures

  1 year

• Number of redirections

  1 year

Study Arms (2)

Ultrasound-assisted localization, US-AS

ACTIVE COMPARATOR

Patients in the US-AS group will undergo a pre-procedural ultrasound scan to identify the optimal intervertebral space, measure the depth to the epidural space, and mark the skin entry point and estimated puncture angle. The ultrasound probe will then be removed, and the combined spinal-epidural anesthesia (CSEA) procedure will be performed via the paramedian approach using the pre-marked landmarks.

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

Real-time ultrasound guidance, US-RTG

EXPERIMENTAL

Patients in the US-RTG group will undergo CSEA via the paramedian approach under continuous real-time ultrasound visualization. The procedure will be performed using either the in-plane technique in the paracentral transverse plane, allowing direct visualization of needle advancement through the soft tissues and into the epidural and subarachnoid spaces.

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 IV.

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

Location

Study Officials

• Wei Mei, Ph.D.

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

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 15, 2024
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)