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Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

Primary Purpose

Preeclampsia

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Levobupivacaine hydrochloride

Magnesium sulphate

Saline 0.9%

About this trial

This is an interventional supportive care trial for Preeclampsia focused on measuring Levobupivacaine, Magnesium, Preeclampsia, Epidural

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

Mansoura University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Magnesium sulphate group

Placebo group

Arm Description

Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate

Patients will receive epidural levobupivacaine hydrochloride + saline 0.9%

Outcomes

Primary Outcome Measures

Pain-free period

The time from reaching sensory block to onset of pain

Secondary Outcome Measures

Full Information

NCT ID

NCT02699827

First Posted

March 1, 2016

Last Updated

June 3, 2017

Sponsor

Mohamed Sayed Abdelhafez

1. Study Identification

Unique Protocol Identification Number

NCT02699827

Brief Title

Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mohamed Sayed Abdelhafez

4. Oversight

Data Monitoring Committee

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preeclampsia

Keywords

Levobupivacaine, Magnesium, Preeclampsia, Epidural

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Magnesium sulphate group

Arm Type

Active Comparator

Arm Description

Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Patients will receive epidural levobupivacaine hydrochloride + saline 0.9%

Intervention Type

Drug

Intervention Name(s)

Levobupivacaine hydrochloride

Other Intervention Name(s)

Chirocaine

Intervention Description

Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%

Intervention Type

Drug

Intervention Name(s)

Magnesium sulphate

Intervention Description

Patients will receive epidural 5 ml magnesium sulphate 10%

Intervention Type

Drug

Intervention Name(s)

Saline 0.9%

Intervention Description

Patients will receive epidural 5 ml saline 0.9%

Primary Outcome Measure Information:

Title

Pain-free period

Description

The time from reaching sensory block to onset of pain

Time Frame

24 hours after the epidural anesthesia

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: