Ultrasound-assisted Versus Real-time Ultrasound-guided Combined Spinal-epidural Anesthesia Via a Paramedian Approach in Elderly Patients: a Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tongji Hospital
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- First-attempt success
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Ultrasound-assisted localization, US-AS (Procedure)
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.
Intervention: Real-time ultrasound guidance, US-RTG (Procedure)
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.
Intervention: Ultrasound-assisted localization, US-AS (Procedure)
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.
Intervention: Real-time ultrasound guidance, US-RTG (Procedure)
Outcomes
Primary Outcomes
First-attempt success
Time Frame: 1 year
The proportion of the first successful puncture to the total successful puncture
Secondary Outcomes
- Patient satisfaction score (How satisfied the patient is with the whole procedure)(1 year)
- Adverse events (AEs)(1 year)
- 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)
- SA needle insertion attempts(1 year)
- Procedural difficulty(1 year)
Investigators
Tianzhu Liu
Principal Investigator
Tongji Hospital