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Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

Sponsor
Mohamed Sayed Abdelhafez (Other)
Overall Status
Completed
CT.gov ID
NCT02699827
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
10.1
Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Levobupivacaine hydrochloride
  • Drug: Magnesium sulphate
  • Drug: Saline 0.9%
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Adding Magnesium Sulphate to Epidural Levobupivacaine in Elective Caesarian Section for Patients With Preeclampsia
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

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%

    Outcome Measures

    Primary Outcome Measures

    1. Pain-free period [24 hours after the epidural anesthesia]

      The time from reaching sensory block to onset of pain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mansoura University Hospital Mansoura Dakahlia Egypt 35111

    Sponsors and Collaborators

    • Mohamed Sayed Abdelhafez

    Investigators

    • Principal Investigator: Tamer Elmetwally, Dr, Mansoura University
    • Study Director: Mohamed S Abdelhafez, Dr, Mansoura University
    • Study Director: Reem A Elsharkawy, Dr, Mansoura University
    • Study Director: Waleed El-refaie, Dr, Mansoura University
    • Study Director: Alaa Wageeh, Dr, Mansoura University
    • Study Chair: Salwa S Hays, Prof, Mansoura University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Sayed Abdelhafez, Dr, Mansoura University
    ClinicalTrials.gov Identifier:
    NCT02699827
    Other Study ID Numbers:
    • TM1
    First Posted:
    Mar 4, 2016
    Last Update Posted:
    Jun 6, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Mohamed Sayed Abdelhafez, Dr, Mansoura University
    Levobupivacaine
    Magnesium
    Preeclampsia
    Epidural
    Additional relevant MeSH terms:
    Pre-Eclampsia
    Magnesium Sulfate
    Levobupivacaine

    Study Results

    No Results Posted as of Jun 6, 2017