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

NCT ID: NCT06241716

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-20

Study Completion Date

2026-01-20

Brief Summary

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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

Detailed Description

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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

Conditions

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Ultrasound Therapy; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Ultrasound-assisted localization, US-AS

Group Type ACTIVE_COMPARATOR

Ultrasound-assisted localization, US-AS

Intervention Type 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

Intervention Type 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.

Real-time ultrasound guidance, US-RTG

Group Type EXPERIMENTAL

Ultrasound-assisted localization, US-AS

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tianzhu Liu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianzhu Liu

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Tianzhu Liu, M.D.

Role: primary

13098866448

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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102114

Identifier Type: -

Identifier Source: org_study_id

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