Two Different Techniques to Perform Epidural Using Ultrasound Clinical Trial
Official title:
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
| NCT number | NCT04204070 |
| Other study ID # | 134/200 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 11, 2019 |
| Est. completion date | June 11, 2020 |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | June 11, 2020 |
| Est. primary completion date | June 11, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years to 45 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Alexandria university | Alexandria |
| Lead Sponsor | Collaborator |
|---|---|
| Alexandria University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the depth of the EDS from skin, | inmm | the procedure time | |
| Primary | 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 | |
| Primary | , 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 | |
| Primary | 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 | compare the incidence of complications associated with each technique. | compare the incidence of complications associated with each technique. | the procedure time |