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

February 2, 2024 updated by: Tianzhu Liu, Tongji Hospital

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

This study aims to compare the clinical effects of ultrasound-assisted localization and real-time ultrasound-guided combined spinal-epidural anesthesia via paramedian approach in elderly patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to compare the clinical effects of ultrasound-assisted localization and real-time ultrasound-guided combined spinal-epidural anesthesia via paramedian approach in elderly patients

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elderly patients (≥ 60 years old);
  • ASA Grade I to III.

Exclusion Criteria:

  • Severe obesity (BMI>35kg/m2);
  • Spinal deformity or surgical history;
  • Allergic to local anesthetics;
  • There are coagulation disorders;
  • Communication barriers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound-assisted localization, US-AS
Procedure: Ultrasound-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.
Procedure: Real-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.
Experimental: Real-time ultrasound guidance, US-RTG
Procedure: Ultrasound-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.
Procedure: Real-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First puncture success rate
Time Frame: 1 year
The proportion of the first successful puncture to the total successful puncture
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: 1 year
The time from the contact of the ultrasonic probe to the end of the operation (In seconds).
1 year
Positioning time
Time Frame: 1 year
The time required for pre-scanning and positioning (In seconds).
1 year
Depth and width of posterior dural complex
Time Frame: 1 year
Obtained by ultrasonic measurement (In centimetres).
1 year
Skin puncture times
Time Frame: 1 year
Count the number of skin piercings (In seconds).
1 year
Number of redirects
Time Frame: 1 year
Count the number of needle redirection
1 year
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
1 year
Operator 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 20, 2024

Primary Completion (Estimated)

October 20, 2025

Study Completion (Estimated)

January 20, 2026

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Estimated)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 102114

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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