Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699827
• Other study ID #: TM1
• Status: Completed
• Phase: Phase 4
• First received: March 1, 2016
• Last updated: June 3, 2017
• Start date: March 2016
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Levobupivacaine hydrochloride
Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%
• Magnesium sulphate
Patients will receive epidural 5 ml magnesium sulphate 10%
• Saline 0.9%
Patients will receive epidural 5 ml saline 0.9%

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Sayed Abdelhafez

Country where clinical trial is conducted

Egypt, 

Outcome

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