Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02699827

Enrollment

Registered

2016-03-04

Start date

2016-03-31

Completion date

2017-01-31

Last updated

2017-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Levobupivacaine, Magnesium, Preeclampsia, Epidural

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%.

Interventions

DRUGLevobupivacaine hydrochloride

Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%

DRUGMagnesium sulphate

Patients will receive epidural 5 ml magnesium sulphate 10%

DRUGSaline 0.9%

Patients will receive epidural 5 ml saline 0.9%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

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.

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026