ClinicalTrials.Veeva

Menu

Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

M

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems