Effect of Epidural Dexamethasone on Labor Analgesia

NCT ID: NCT02665936

Last Updated: 2016-01-28

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-02-29

Brief Summary

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The purpose of this study is to detect whether the addition of epidural dexamethasone will prolong labor analgesia.

Detailed Description

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Conditions

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Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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group L

Epidural levobupivacaine 0.125% (Chirocaine) in normal saline in a total volume of 10 ml will be administered epidurally in active stage of labor

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Levobupivacaine will be given epidurally and the duration of analgesia will be calculated

group LD4

Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 4 mg in a total volume 10 ml

Group Type ACTIVE_COMPARATOR

Dexamethasone and levobupivacaine

Intervention Type DRUG

dexamethasone 4 mg epidurally with levobupivacaine and duration of analgesia is measured

group LD8

Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 8 mg in a total volume 10 ml

Group Type ACTIVE_COMPARATOR

Levobupivacaine and Dexamethasone

Intervention Type DRUG

dexamethasone 8 mg epidurally with levobupivacaine and duration of analgesia is measured

Interventions

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Levobupivacaine

Levobupivacaine will be given epidurally and the duration of analgesia will be calculated

Intervention Type DRUG

Dexamethasone and levobupivacaine

dexamethasone 4 mg epidurally with levobupivacaine and duration of analgesia is measured

Intervention Type DRUG

Levobupivacaine and Dexamethasone

dexamethasone 8 mg epidurally with levobupivacaine and duration of analgesia is measured

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I, II
* normal vaginal delivery In early active phase of labor
* singleton cephalic presentation at term

Exclusion Criteria

* complicated pregnancies
* morbid obesity
* diagnosed fetal abnormalities
* contra-indications to regional anesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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ahmed elsakka

m.d. anasthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed i elsakka, m,d,

Role: PRINCIPAL_INVESTIGATOR

Cairo University

amira r hassan, m,d.

Role: STUDY_CHAIR

Cairo University

nadia y helmy, m.d.

Role: STUDY_DIRECTOR

Cairo University

Other Identifiers

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wahdan

Identifier Type: -

Identifier Source: org_study_id

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