Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

Mohamed Sayed Abdelhafez

Status and phase: Completed; Phase 4

Conditions: Preeclampsia

Treatments: Drug: Levobupivacaine hydrochloride; Drug: Saline 0.9%; Drug: Magnesium sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT02699827

TM1

Details and patient eligibility

About

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).

Full 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%.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

Magnesium sulphate group

Active Comparator group

Description:

Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate

Treatment:

Drug: Magnesium sulphate

Drug: Levobupivacaine hydrochloride

Placebo group

Placebo Comparator group

Description:

Patients will receive epidural levobupivacaine hydrochloride + saline 0.9%

Treatment:

Drug: Saline 0.9%

Drug: Levobupivacaine hydrochloride