Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-01-31

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).

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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%.

Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Magnesium sulphate group

Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate

Group Type ACTIVE_COMPARATOR

Levobupivacaine hydrochloride

Intervention Type DRUG

Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%

Magnesium sulphate

Intervention Type DRUG

Patients will receive epidural 5 ml magnesium sulphate 10%

Placebo group

Patients will receive epidural levobupivacaine hydrochloride + saline 0.9%

Group Type PLACEBO_COMPARATOR

Levobupivacaine hydrochloride

Intervention Type DRUG

Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%

Saline 0.9%

Intervention Type DRUG

Patients will receive epidural 5 ml saline 0.9%

Interventions

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Levobupivacaine hydrochloride

Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%

Intervention Type DRUG

Magnesium sulphate

Patients will receive epidural 5 ml magnesium sulphate 10%

Intervention Type DRUG

Saline 0.9%

Patients will receive epidural 5 ml saline 0.9%

Intervention Type DRUG

Other Intervention Names

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Chirocaine

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No