Dural Puncture Epidural Technique For Vaginal Procedures

August 30, 2023 updated by: Reham Ali Abdelhaleem Abdelrahman, Cairo University

Comparative Study Between Dural Puncture Epidural Technique and Conventional Epidural Technique During Laparoscopic Assisted Vaginal Hysterectomy

25G Dural Puncture Epidural Technique will be compared with Conventional Standard Lumbar Epidural Technique During Anesthesia of Laparoscopic Assisted Vaginal Hysterectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Department of Anesthesia, Surgical ICU, and Pain Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age: 25-55 years old.
  • Height: 165 cm.

Exclusion Criteria:

  • Patient Refusal.
  • Coagulopathy.
  • Deformity of lumbar vertebrae.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Epidural Technique
Procedure: 25G Dural Puncture Epidural Technique
25G pencil point spinal needle will be inserted at L4-5 interspace through the tuhoy needle
Active Comparator: Dural Puncture Epidural technique using pencil-point 25G Whitacre needle
Procedure: Conventional Epidural Technique
Standard Lumbar Epidural Technique at L4-5 interspace using Tuhoy needle (18G) then epidural catheter (20G) inserted, then 15ml 0.5% Bupivacane and 50ug fentanyl given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of bilateral sacral blockade
Time Frame: Up to 30 minutes after local anesthetic injection
Up to 30 minutes after local anesthetic injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

February 19, 2023

Study Registration Dates

First Submitted

August 28, 2021

First Submitted That Met QC Criteria

August 28, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZO-19251

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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