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NCT Number: NCT06241716

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

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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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianzhu Liu

Wuhan, Hubei, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-assisted localization, US-AS

Procedure

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.

Real-time ultrasound guidance, US-RTG

Procedure

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.

Primary outcomes

  1. First-attempt success

    Time frame: 1 year

    The proportion of the first successful puncture to the total successful puncture

Secondary outcomes

  1. Operating time

    Time frame: 1 year

    The time from the contact of the ultrasonic probe to the end of the operation (In seconds).

  2. Location time

    Time frame: 1 year

    The time required for pre-scanning and positioning (In seconds).

  3. Depth and width of posterior dural complex (DPEC, WPEC)

    Time frame: 1 year

    DPEC = Depth to Posterior Epidural Complex, WPEC = Width of Posterior Epidural Complex

  4. Number of skin punctures

    Time frame: 1 year

    Count the number of skin piercings (In seconds).

  5. Number of redirections

    Time frame: 1 year

    Count the number of needle redirection

  6. Patient satisfaction score (How satisfied the patient is with the whole procedure)

    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

  7. SA needle insertion attempts

    Time frame: 1 year

    Times of SA needle inserting via the epidural needle

  8. Adverse events (AEs)

    Time frame: 1 year

    Adverse events that occurred during the operation process.

  9. Procedural difficulty

    Time frame: 1 year

    Procedural difficulty of palpating spinous processes was assessed as Grade 1 (palpable), Grade 2 (somewhat palpable), or Grade 3 (impalpable)

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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