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

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Between Ultrasound Assisted Epidural Catheter Placement Using Accuro and the Use of Ultra Sound Real Time With Acoustic Puncture Assisted Device to Confirm Epidural Space End Point

Conditions
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Two Different Techniques to Perform Epidural Using Ultrasound

Intervention / Treatment
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* Procedure: Accuro
* Procedure: APAD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I Accuro<br>epidural catheter insertion using the Accuro ultrasound imaging assisted technique | Procedure: Accuro<br>* A research coordinator recorded the depth of the EDS from skin, 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 time taken for space localisation (it is defined as time taken in seconds from skin puncture until the successful space localisation).the total time of the procedure ( time measured from the patient is fully draped and in the proper sitting position till the end of insertion of the epidural catheter ) Any complications such as paresthesia during catheter insertion, dural puncture, blood in catheter and root irritation will be recorded<br>|
| Experimental: Group II APAD<br>epidural catheter insertion using the real time ultrasound guided technique combined with the use of the acoustic puncture assist device (APAD) technique. | Procedure: APAD<br>* APAD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the depth of the EDS from skin, | inmm | 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 | 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 time taken for space localisation . | (it is defined as time taken in seconds from skin puncture until the successful space localisation) | the procedure time | 
| the total time of the procedure | ( time measured from the patient is fully draped and in the proper sitting position till the end of insertion of the epidural catheter ) | the procedure time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the incidence of complications associated with each technique. | compare the incidence of complications associated with each technique. | the procedure time |