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

Not Applicable

• Conditions: Two Different Techniques to Perform Epidural Using Ultrasound
• Interventions: Procedure: Accuro; Procedure: APAD

• Registration Number: NCT04204070
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-11
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-18
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-12
• Last Update Posted: 2020-04-14
• Primary Completion: 2020-06-11
• Study Completion: 2020-06-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• • Any contraindication for epidural analgesia

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I Accuro	Accuro	epidural catheter insertion using the Accuro ultrasound imaging assisted technique
Group II APAD	APAD	epidural catheter insertion using the real time ultrasound guided technique combined with the use of the acoustic puncture assist device (APAD) technique.

Primary Outcome Measures

Name	Time	Method
the depth of the EDS from skin,	the procedure time	inmm
the total time of the procedure	the procedure time	( time measured from the patient is fully draped and in the proper sitting position till the end of insertion of the epidural catheter )
, the time taken for space localisation .	the procedure time	(it is defined as time taken in seconds from skin puncture until the successful space localisation)
the number of attempts to perform the epidural anesthesia, the repositioning of the epidural needle either in the same space or in different space	the procedure time	the number of attempts to perform the epidural anesthesia, the repositioning of the epidural needle either in the same space or in different space

Secondary Outcome Measures

Name	Time	Method
compare the incidence of complications associated with each technique.	the procedure time	compare the incidence of complications associated with each technique.

Trial Locations

Locations (1)

Alexandria university; 🇪🇬 Alexandria, Egypt