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Dural Puncture Epidural Technique Versus Conventional Epidural Techmique

NCT ID: NCT05032677

Last Updated: 2022-12-15

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

2021-08-18

Study Completion Date

2022-12-10

Brief Summary

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This study will be conducted on 50 patients of ASA grade I and II aged from 25 to 55 years and presented for laparoscopic hysterectomy. Patients will be divided into two equal groups; group A control group for conventional epidural technique(n=25) and group B for 25G dural puncture epidural with 25G pencil point Whitacre spinal needle (n=25). Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.

Detailed Description

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Conditions

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Gynecologic Disease Requiring Laparoscopic Hysterectomy Under Neuraxial Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Conventional Epidural Technique

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

25G Dural Puncture Epidural Block at L2-3 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.

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

Group Type ACTIVE_COMPARATOR

Conventional Epidural Technique

Intervention Type PROCEDURE

Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L2-3 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.

Interventions

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Conventional Epidural Technique

Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L2-3 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.

Intervention Type PROCEDURE

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

25G Dural Puncture Epidural Block at L2-3 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I and II
* Height(150-170 cm)

Exclusion Criteria

* patient refusal
* hypersensitivity to local anesthetic drugs
* bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5 or therapeutic dose of anticoagulant).
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

Principal Investigators

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Reham Ali Abdelrahman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

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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ES-2022

Identifier Type: -

Identifier Source: org_study_id