Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

June 3, 2017 updated by: Mohamed Sayed Abdelhafez

Adding Magnesium Sulphate to Epidural Levobupivacaine in Elective Caesarian Section for Patients With Preeclampsia

This study aims at evaluating the effect of adding magnesium sulphate epidurally as an adjunct to levobupivacaine on the quality of anesthesia and perioperative pain relief in patients with preeclampsia undergoing elective caesarian section (CS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pregnant women with preeclampsia undergoing elective CS in will be included in the study. All patients participating in the study will be randomly divided into two groups; magnesium sulphate group (study group) and placebo group (control group). Patients in the study group will receive epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml magnesium sulphate 10% (500 mg) while patients in the control group will received epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml saline 0.9%.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35111
        • Mansoura University Hospital

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

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women with preeclampsia undergoing elective CS.

Exclusion Criteria:

  • Age < 20 or > 35 years.
  • Height < 150 or > 180 cm.
  • Body mass index (BMI) > 35 kg/m2.
  • Active labor.
  • Multifetal pregnancy.
  • Fetal distress.
  • Medical conditions complicating pregnancy.
  • HELLP syndrome.
  • Thrombocytopenia.
  • Hepatic or renal impairment.
  • Pulmonary edema or cyanosis.
  • Placenta previa.
  • Vaginal bleeding or placental abruption.
  • Contraindication for central neuraxial block.
  • History of adverse reaction to any study medication.
  • History of analgesic use.
  • Magnesium therapy.
  • Chronic pain syndrome.
  • Presence of communication difficulties preventing reliable assessment.
  • Refusal to undergo 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Magnesium sulphate group
Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate
Drug: Levobupivacaine hydrochloride
Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%
Other Names:
  • Chirocaine
Drug: Magnesium sulphate
Patients will receive epidural 5 ml magnesium sulphate 10%
Placebo Comparator: Placebo group
Patients will receive epidural levobupivacaine hydrochloride + saline 0.9%
Drug: Levobupivacaine hydrochloride
Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%
Other Names:
  • Chirocaine
Drug: Saline 0.9%
Patients will receive epidural 5 ml saline 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain-free period
Time Frame: 24 hours after the epidural anesthesia
The time from reaching sensory block to onset of pain
24 hours after the epidural anesthesia

Collaborators and Investigators

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

Sponsor

Mohamed Sayed Abdelhafez

Investigators

  • Principal Investigator: Tamer Elmetwally, Dr, Mansoura University
  • Study Director: Reem A Elsharkawy, Dr, Mansoura University
  • Study Director: Alaa Wageeh, Dr, Mansoura University
  • Study Chair: Salwa S Hays, Prof, Mansoura 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

March 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 3, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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