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Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

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ClinicalTrials.gov Identifier: NCT02699827
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Sayed Abdelhafez, Mansoura University

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
Preeclampsia 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%.

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Study Type : Interventional  (Clinical Trial)
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 : March 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017


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 Name: 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 Name: Chirocaine

Drug: Saline 0.9%
Patients will receive epidural 5 ml saline 0.9%




Primary Outcome Measures :
  1. Pain-free period [ Time Frame: 24 hours after the epidural anesthesia ]
    The time from reaching sensory block to onset of pain



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699827


Locations
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Egypt
Mansoura University Hospital
Mansoura, Dakahlia, Egypt, 35111
Sponsors and Collaborators
Mohamed Sayed Abdelhafez
Investigators
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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
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Responsible Party: Mohamed Sayed Abdelhafez, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02699827    
Other Study ID Numbers: TM1
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mohamed Sayed Abdelhafez, Mansoura University:
Levobupivacaine
Magnesium
Preeclampsia
Epidural
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Levobupivacaine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents
Anesthetics, Local