Ultrasound Therapy; ComplicationsNCT06241716
Ultrasound-assisted Versus Real-time Ultrasound-guided Combined Spinal-epidural Anesthesia in Elderly Patients
A study testing Ultrasound-assisted localization, US-AS and Real-time ultrasound guidance, US-RTG in people with Ultrasound Therapy; Complications, run by Tongji Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Ultrasound Therapy; Complications
- What is being tested?
- Ultrasound-assisted localization, US-AS and Real-time ultrasound guidance, US-RTG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2024to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients (≥ 60 years old);
- ASA Grade I to IV.
Who cannot join
- Severe obesity (BMI>35kg/m2);
- Spinal deformity or surgical history;
- Allergic to local anesthetics;
- There are coagulation disorders;
- Communication barriers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-assisted Versus Real-time Ultrasound-guided Combined Spinal-epidural Anesthesia Via a Paramedian Approach in Elderly Patients: a Randomized Controlled Study
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.
Read the 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.
- Conditions
- Ultrasound Therapy; Complications
- Being tested
- Ultrasound-assisted localization, US-AS, Real-time ultrasound guidance, US-RTG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-assisted localization, US-ASProcedure or surgery
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-RTGProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-assisted localization, US-AS | Active comparator | 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. Receives: Procedure: Ultrasound-assisted localization, US-AS; Procedure: Real-time ultrasound guidance, US-RTG |
| Real-time ultrasound guidance, US-RTG | Experimental | 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. Receives: Procedure: Ultrasound-assisted localization, US-AS; Procedure: Real-time ultrasound guidance, US-RTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-attempt success
The proportion of the first successful puncture to the total successful puncture
Measured: 1 year
Secondary outcomes (9)
Operating time
The time from the contact of the ultrasonic probe to the end of the operation (In seconds).
Measured: 1 year
Location time
The time required for pre-scanning and positioning (In seconds).
Measured: 1 year
Depth and width of posterior dural complex (DPEC, WPEC)
DPEC = Depth to Posterior Epidural Complex, WPEC = Width of Posterior Epidural Complex
Measured: 1 year
Number of skin punctures
Count the number of skin piercings (In seconds).
Measured: 1 year
Number of redirections
Count the number of needle redirection
Measured: 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
Measured: 1 year
SA needle insertion attempts
Times of SA needle inserting via the epidural needle
Measured: 1 year
Adverse events (AEs)
Adverse events that occurred during the operation process.
Measured: 1 year
Procedural difficulty
Procedural difficulty of palpating spinous processes was assessed as Grade 1 (palpable), Grade 2 (somewhat palpable), or Grade 3 (impalpable)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Feb 2024
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianzhu Liu, Tongji Hospital
- Investigators
- Wei Mei, Ph.D., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241716
- Sponsor's protocol ID
- 102114
- Status last verified
- May 2026
- First submitted
- 4 Jan 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-assisted Versus Real-time Ultrasound-guided Combined Spinal-epidural Anesthesia Via a Paramedian Approach in Elderly Patients: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06241716
- Acronym / sponsor ID
- 102114
- Conditions
- Ultrasound Therapy; Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-assisted localization, US-AS | Active comparator | Procedure: Ultrasound-assisted localization, US-AS, Procedure: Real-time ultrasound guidance, US-RTGPatients 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. |
| Real-time ultrasound guidance, US-RTG | Experimental | Procedure: Ultrasound-assisted localization, US-AS, Procedure: Real-time ultrasound guidance, US-RTGPatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elderly patients (≥ 60 years old);
- ASA Grade I to IV.
Key exclusion criteria (5 listed)
- Severe obesity (BMI>35kg/m2);
- Spinal deformity or surgical history;
- Allergic to local anesthetics;
- There are coagulation disorders;
- Communication barriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-assisted localization, US-ASIn 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. | Procedure or surgery | Real-time ultrasound guidance, US-RTG, Ultrasound-assisted localization, US-AS |
| Real-time ultrasound guidance, US-RTGIn 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. | Procedure or surgery | Real-time ultrasound guidance, US-RTG, Ultrasound-assisted localization, US-AS |
Primary outcome
First-attempt success
Time frame: 1 year
The proportion of the first successful puncture to the total successful puncture
9 secondary outcomes
Operating time
Time frame: 1 year
Location time
Time frame: 1 year
Depth and width of posterior dural complex (DPEC, WPEC)
Time frame: 1 year
Number of skin punctures
Time frame: 1 year
Number of redirections
Time frame: 1 year
Patient satisfaction score (How satisfied the patient is with the whole procedure)
Time frame: 1 year
SA needle insertion attempts
Time frame: 1 year
Adverse events (AEs)
Time frame: 1 year
Procedural difficulty
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Mei, Ph.D. principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-assisted localization, US-AS and Real-time ultrasound guidance, US-RTG in people with Ultrasound Therapy; Complications, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-attempt success (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.