Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

Phase 4

Completed

• Conditions: Preeclampsia
• Interventions: Drug: Levobupivacaine hydrochloride; Drug: Saline 0.9%; Drug: Magnesium sulphate

• Registration Number: NCT02699827
• Lead Sponsor: Mohamed Sayed Abdelhafez

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).

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-04
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-03
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium sulphate group	Levobupivacaine hydrochloride	Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate
Placebo group	Levobupivacaine hydrochloride	Patients will receive epidural levobupivacaine hydrochloride + saline 0.9%
Placebo group	Saline 0.9%	Patients will receive epidural levobupivacaine hydrochloride + saline 0.9%
Magnesium sulphate group	Magnesium sulphate	Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate

Primary Outcome Measures

Name	Time	Method
Pain-free period	24 hours after the epidural anesthesia	The time from reaching sensory block to onset of pain

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt