Ultrasound Therapy; Complications
Conditions
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.
Interventions
PROCEDUREUltrasound-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.
PROCEDUREReal-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.
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-attempt success | 1 year | The proportion of the first successful puncture to the total successful puncture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating time | 1 year | The time from the contact of the ultrasonic probe to the end of the operation (In seconds). |
| Location time | 1 year | The time required for pre-scanning and positioning (In seconds). |
| Depth and width of posterior dural complex (DPEC, WPEC) | 1 year | DPEC = Depth to Posterior Epidural Complex, WPEC = Width of Posterior Epidural Complex |
| Number of skin punctures | 1 year | Count the number of skin piercings (In seconds). |
| Number of redirections | 1 year | Count the number of needle redirection |
| Patient satisfaction score (How satisfied the patient is with the whole procedure) | 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 |
| SA needle insertion attempts | 1 year | Times of SA needle inserting via the epidural needle |
| Adverse events (AEs) | 1 year | Adverse events that occurred during the operation process. |
| Procedural difficulty | 1 year | Procedural difficulty of palpating spinous processes was assessed as Grade 1 (palpable), Grade 2 (somewhat palpable), or Grade 3 (impalpable) |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORWei Mei, Ph.D.
Tongji Hospital
Outcome results
None listed