Tianzhu Liu
Wuhan, Hubei, 430000, China
NCT Number: NCT06241716
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.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Wuhan, Hubei, 430000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 year
The proportion of the first successful puncture to the total successful puncture
Time frame: 1 year
The time from the contact of the ultrasonic probe to the end of the operation (In seconds).
Time frame: 1 year
The time required for pre-scanning and positioning (In seconds).
Time frame: 1 year
DPEC = Depth to Posterior Epidural Complex, WPEC = Width of Posterior Epidural Complex
Time frame: 1 year
Count the number of skin piercings (In seconds).
Time frame: 1 year
Count the number of needle redirection
Time frame: 1 year
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
Times of SA needle inserting via the epidural needle
Time frame: 1 year
Adverse events that occurred during the operation process.
Time frame: 1 year
Procedural difficulty of palpating spinous processes was assessed as Grade 1 (palpable), Grade 2 (somewhat palpable), or Grade 3 (impalpable)
Tongji Hospital
Other
Ultrasound-assisted Versus Real-time Ultrasound-guided Combined Spinal-epidural Anesthesia Via a Paramedian Approach in Elderly Patients: a Randomized Controlled Study
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