Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

Study Overview
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Brief Summary
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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).

Detailed Description
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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%.

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

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Levobupivacaine hydrochloride
* Drug: Magnesium sulphate
* Drug: Saline 0.9%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium sulphate group<br>Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate | Drug: Levobupivacaine hydrochloride<br>* Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%<br>* Other names: Chirocaine;Drug: Magnesium sulphate<br>* Patients will receive epidural 5 ml magnesium sulphate 10%<br>|
| Placebo Comparator: Placebo group<br>Patients will receive epidural levobupivacaine hydrochloride + saline 0.9% | Drug: Levobupivacaine hydrochloride<br>* Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%<br>* Other names: Chirocaine;Drug: Saline 0.9%<br>* Patients will receive epidural 5 ml saline 0.9%<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levobupivacaine, Magnesium, Preeclampsia, Epidural