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NCT Number: NCT02699827

Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

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).

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine hydrochloride

Drug

Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%

Other names: Chirocaine

Magnesium sulphate

Drug

Patients will receive epidural 5 ml magnesium sulphate 10%

saline 0.9%

Drug

Patients will receive epidural 5 ml saline 0.9%

Primary outcomes

  1. Pain-free period

    Time frame: 24 hours after the epidural anesthesia

    The time from reaching sensory block to onset of pain

Sponsors and collaborators

Lead sponsor

Mohamed Sayed Abdelhafez

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 4, 2016
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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