NCT02699827

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

10 months

First QC Date

March 1, 2016

Last Update Submit

June 3, 2017

Conditions

Preeclampsia

Keywords

LevobupivacaineMagnesiumPreeclampsiaEpidural

Outcome Measures

Primary Outcomes (1)

  • Pain-free period

    The time from reaching sensory block to onset of pain

    24 hours after the epidural anesthesia

Study Arms (2)

Magnesium sulphate group

ACTIVE COMPARATOR

Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate

Drug: Levobupivacaine hydrochlorideDrug: Magnesium sulphate

Placebo group

PLACEBO COMPARATOR

Patients will receive epidural levobupivacaine hydrochloride + saline 0.9%

Drug: Levobupivacaine hydrochlorideDrug: Saline 0.9%

Interventions

Levobupivacaine hydrochlorideDRUG

Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%

Also known as: Chirocaine
Magnesium sulphate groupPlacebo group
Magnesium sulphateDRUG

Patients will receive epidural 5 ml magnesium sulphate 10%

Magnesium sulphate group
Saline 0.9%DRUG

Patients will receive epidural 5 ml saline 0.9%

Placebo group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women with preeclampsia undergoing elective CS.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

LevobupivacaineMagnesium SulfateSodium Chloride

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Officials

  • Tamer Elmetwally, Dr

    Mansoura University

    PRINCIPAL INVESTIGATOR

  • Mohamed S Abdelhafez, Dr

    Mansoura University

    STUDY DIRECTOR

  • Reem A Elsharkawy, Dr

    Mansoura University

    STUDY DIRECTOR

  • Waleed El-refaie, Dr

    Mansoura University

    STUDY DIRECTOR

  • Alaa Wageeh, Dr

    Mansoura University

    STUDY DIRECTOR

  • Salwa S Hays, Prof

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 4, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations

EG(1)