Accuro and the Use of Real Time Ultra Sound With Acoustic Puncture Assisted Device to Confirm Epidural Space End Point

Alexandria University

Status: Unknown

Conditions: Two Different Techniques to Perform Epidural Using Ultrasound

Treatments: Procedure: Accuro; Procedure: APAD

Study type: Interventional

Funder types: Other

Identifiers

NCT04204070

134/200

Details and patient eligibility

About

Aim of the work:

To compare the use of the Accuro ultrasound and a real time ultrasound guided epidural combined with the acoustic puncture assisted device to perform the epidural anesthesia Secondary aim is to compare the incidence of complications associated with each technique.

Patient's selection:

This study will be performed on 100 pregnant patients scheduled for normal vaginal delivery under epidural analgesia.

The sample size was calculated by taking success rate of conventional LOR to be 98% in the patients; assuming 80% power, with 95% confidence interval (CI) of two techniques and 30% margin of error.

The study protocol will be reviewed and approved by the Ethics Committee of the Alexandria Main University Hospitals.

A written consent will be obtained from all the patients participating in this study.

Complete history will be taken from all the patients and will be subjected to thorough examination and routine laboratory investigations. Patients will be randomly divided into two equal groups using a computer-generated program.

Group I consists of 50 patients scheduled for epidural catheter insertion using the Accuro ultrasound imaging assisted technique.

Group II consists of 50 patients scheduled for epidural catheter insertion using the real time ultrasound guided technique combined with the use of the acoustic puncture assist device (APAD) technique.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• pregnant patients scheduled for normal vaginal delivery under epidural analgesia.

Exclusion criteria

• • Any contraindication for epidural analgesia

  • High risk pregnancy or precious baby.
  • Patients not willing for participation.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Group I Accuro

Experimental group

Description:

epidural catheter insertion using the Accuro ultrasound imaging assisted technique

Treatment:

Procedure: Accuro

Group II APAD

Experimental group

Description:

epidural catheter insertion using the real time ultrasound guided technique combined with the use of the acoustic puncture assist device (APAD) technique.

Treatment:

Procedure: APAD