Dural Puncture Epidural Technique For Vaginal Procedures

NCT ID: NCT05031117

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2023-02-19

Brief Summary

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

Detailed Description

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Conditions

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Gynecologic Diseases Requiring Vaginal Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Conventional Epidural Technique

Group Type EXPERIMENTAL

25G Dural Puncture Epidural Technique

Intervention Type PROCEDURE

25G pencil point spinal needle will be inserted at L4-5 interspace through the tuhoy needle

Dural Puncture Epidural technique using pencil-point 25G Whitacre needle

Group Type ACTIVE_COMPARATOR

Conventional Epidural Technique

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

25G Dural Puncture Epidural Technique

25G pencil point spinal needle will be inserted at L4-5 interspace through the tuhoy needle

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patient Refusal.
* Coagulopathy.
* Deformity of lumbar vertebrae.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Reham Ali Abdelhaleem Abdelrahman

Anesthesia lecturer M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesia, Surgical ICU, and Pain Management

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ZO-19251

Identifier Type: -

Identifier Source: org_study_id

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