An interventional study of Ultrasound-assisted localization, US-AS and Real-time ultrasound guidance, US-RTG in Ultrasound Therapy; Complications, sponsored by Tongji Hospital. Completed at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Tongji Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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.
First-attempt success
The proportion of the first successful puncture to the total successful puncture
Time frame: 1 year
Operating time
The time from the contact of the ultrasonic probe to the end of the operation (In seconds).
Time frame: 1 year
Location time
The time required for pre-scanning and positioning (In seconds).
Time frame: 1 year
Depth and width of posterior dural complex (DPEC, WPEC)
DPEC = Depth to Posterior Epidural Complex, WPEC = Width of Posterior Epidural Complex
Time frame: 1 year
Number of skin punctures
Count the number of skin piercings (In seconds).
Time frame: 1 year
Number of redirections
Count the number of needle redirection
Time frame: 1 year
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
Time frame: 1 year
SA needle insertion attempts
Times of SA needle inserting via the epidural needle
Time frame: 1 year
Adverse events (AEs)
Adverse events that occurred during the operation process.
Time frame: 1 year
Procedural difficulty
Procedural difficulty of palpating spinous processes was assessed as Grade 1 (palpable), Grade 2 (somewhat palpable), or Grade 3 (impalpable)
Time frame: 1 year
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tongji Hospital