Effect of Epidural Dexamethasone on Labor Analgesia

January 27, 2016 updated by: ahmed elsakka, Kasr El Aini Hospital

Epidural Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Epidural for Vaginal Delivery Analgesia: A Comparative, Dose Ranging and Safety Evaluation Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

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

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Levobupivacaine
Levobupivacaine will be given epidurally and the duration of analgesia will be calculated
Active Comparator: group LD4
Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 4 mg in a total volume 10 ml
Drug: Dexamethasone and levobupivacaine
dexamethasone 4 mg epidurally with levobupivacaine and duration of analgesia is measured
Active Comparator: group LD8
Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 8 mg in a total volume 10 ml
Drug: Levobupivacaine and Dexamethasone
dexamethasone 8 mg epidurally with levobupivacaine and duration of analgesia is measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of epidural analgesia
Time Frame: an average of 5 months
an average of 5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of onset of sensory block at level T10
Time Frame: an average of 5 months
From the onset of active stage till the end of labor
an average of 5 months

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: ahmed i elsakka, m,d,, Cairo University
  • Study Chair: amira r hassan, m,d., Cairo University
  • Study Director: nadia y helmy, m.d., Cairo University

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

October 1, 2015

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wahdan

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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