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

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

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.

Study Overview

• Status: Completed
• Conditions: Ultrasound Therapy; Complications
• Intervention / Treatment: Procedure: Ultrasound-assisted localization, US-AS; Procedure: Real-time ultrasound guidance, US-RTG

Detailed Description

Elderly patients frequently present with age-related spinal degeneration, which significantly increases the technical difficulty of combined spinal-epidural anesthesia (CSEA) and elevates the risk of puncture-related complications. Ultrasound guidance has emerged as a valuable tool to improve neuraxial anesthesia outcomes, but the optimal ultrasound technique for CSEA in this vulnerable population remains unclear.

Two predominant ultrasound approaches are currently utilized in clinical practice: static ultrasound-assisted mapping (US-AS), which involves pre-procedural identification of spinal landmarks, and real-time ultrasound guidance (US-RTG), which provides continuous visualization of needle advancement during the procedure. However, there is limited high-quality evidence directly comparing these two techniques specifically for CSEA in elderly patients undergoing orthopedic surgery.

This prospective randomized controlled trial will enroll 96 eligible patients aged 60 years and older scheduled for elective orthopedic surgery under CSEA. Eligible patients will be randomly assigned in a 1:1 ratio to receive either US-RTG or US-AS for CSEA placement via the paramedian approach.

The primary outcome measure is the first-attempt success rate, defined as successful dural puncture achieved with a single skin puncture and no needle redirections. Secondary outcome measures include the number of subarachnoid (SA) needle insertion attempts, number of skin punctures, overall incidence of adverse events (AEs), and patient satisfaction scores. Subgroup analyses will be performed to evaluate the efficacy of the two techniques across varying epidural dimensions, and a learning curve analysis will be conducted to assess the procedural proficiency plateau for US-RTG.

The results of this study will provide evidence-based guidance for the selection of optimal ultrasound techniques for CSEA in elderly patients, with the potential to reduce procedural tissue trauma, minimize puncture-related complications, and improve patient safety and satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Tianzhu Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound-assisted localization, US-AS; 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; 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.; Procedure: 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.
Experimental: Real-time ultrasound guidance, US-RTG; 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; 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.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-attempt success	The proportion of the first successful puncture to the total successful puncture	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Operating time	The time from the contact of the ultrasonic probe to the end of the operation (In seconds).	1 year
Location time	The time required for pre-scanning and positioning (In seconds).	1 year
Depth and width of posterior dural complex (DPEC, WPEC)	DPEC = Depth to Posterior Epidural Complex, WPEC = Width of Posterior Epidural Complex	1 year
Number of skin punctures	Count the number of skin piercings (In seconds).	1 year
Number of redirections	Count the number of needle redirection	1 year
SA needle insertion attempts	Times of SA needle inserting via the epidural needle	1 year
Adverse events (AEs)	Adverse events that occurred during the operation process.	1 year
Procedural difficulty	Procedural difficulty of palpating spinous processes was assessed as Grade 1 (palpable), Grade 2 (somewhat palpable), or Grade 3 (impalpable)	1 year

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Wei Mei, Ph.D., Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): October 20, 2025
• Study Completion (Actual): October 20, 2025

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 102114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No