Regional Anesthesia

December 13, 2022 updated by: Reham Ali Abdelhaleem Abdelrahman

Comparative Study Between Dural Puncture Epidural Technique and Conventional Epidural Technique During Elective Gynecological Vaginal Surgeries

Both techniques are efficacious for sacral anesthesia during vaginal surgeries. Dural puncture epidural technique allows partial confirmation of epidural catheter placement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

88

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
        • Abdelrahman

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

21 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

adult female Egyptian patients

Description

Inclusion Criteria:

  • ASA I-II

    --Age(25-55)years

  • Height(150-170cm)

Exclusion Criteria:

  • patient refusal
  • severe mitral or aortic stenosis

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conventional epidural
epidural needle: Tuhoy needle 1.3mm (18 G) with 20G multi-orifice epidural catheter
Dural puncture epidural
epidural needle;Tuhoy needle 1.3mm (18G)with 20G multi-orifice epidural catheter and 25G Whitacre spinal needle
Device: Whitacre spinal needle
25G Whitacre spinal needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of bilateral sacral sensory loss
Time Frame: 4months
sacral sensory loss is observed by needle brick
4months

Collaborators and Investigators

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

Sponsor

Reham Ali Abdelhaleem Abdelrahman

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)

July 1, 2021

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Estimate)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • AL-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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