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Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries

NCT ID: NCT04921761

Last Updated: 2021-11-22

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-11-01

Brief Summary

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The study aims to evaluate whether the dural puncture epidural technique (group B) improves sacral block anesthesia during vaginal surgeries compared with the conventional epidural technique (group A).

Detailed Description

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Conditions

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Dural Puncture Epidural Technique

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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Group A

Women who received the conventional epidural technique (group A). Intervention: Procedure: Conventional epidural

Group Type PLACEBO_COMPARATOR

Conventional epidural

Intervention Type PROCEDURE

In this group, a 20-gauge multi-orifice catheter was threaded through the cephalic-directed tip of the epidural needle 5 cm into the epidural space.

Group B

Women who received the dural puncture epidural technique (group B). Intervention: Procedure: Dural puncture epidural

Group Type ACTIVE_COMPARATOR

Dural puncture epidural

Intervention Type PROCEDURE

In this group, the dura was punctured by 25G Whitacre needle. After confirmation of CSF flow, the needle was removed and the epidural catheter was threaded.

Interventions

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Conventional epidural

In this group, a 20-gauge multi-orifice catheter was threaded through the cephalic-directed tip of the epidural needle 5 cm into the epidural space.

Intervention Type PROCEDURE

Dural puncture epidural

In this group, the dura was punctured by 25G Whitacre needle. After confirmation of CSF flow, the needle was removed and the epidural catheter was threaded.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Age (25- 55) years. Height (150 -170) cm.

Exclusion Criteria

Patient refusal. Hypersensitivity to local anesthetic drugs. Bleeding disorders and coagulopathy. Severe mitral or aortic stenosis. Local or systemic sepsis. Uncooperative patients. Sever spinal deformity. Blood or CSF in the epidural catheter during the procedure. Failure of the block and need for general anesthesia.
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 collaborator

National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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Egypt

Other Identifiers

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Dural Puncture

Identifier Type: -

Identifier Source: org_study_id