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

Tongji Hospital96 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Ultrasound Therapy; Complications

Interventions

Ultrasound-assisted localization, US-ASPROCEDURE

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

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.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Tianzhu Liu

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

First puncture success rate

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

Time frame: 1 year

Secondary Outcomes

Procedure time

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

Time frame: 1 year

Positioning time

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

Time frame: 1 year

Depth and width of posterior dural complex

Obtained by ultrasonic measurement (In centimetres).

Time frame: 1 year

Skin puncture times

Count the number of skin piercings (In seconds).

Time frame: 1 year

Number of redirects

Count the number of needle redirection

Time frame: 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

Time frame: 1 year

Operator 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

Time frame: 1 year

Data from ClinicalTrials.gov

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