Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor
NCT ID: NCT04397406
Last Updated: 2022-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2020-07-01
2021-10-31
Brief Summary
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The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and safety.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Group C (Control group): Epidural analgesia with levobupivacaine alone Group D (Dexmedetomidine group): Epidural analgesia with levobupivacaine and dexmedetomidine Group F (Fentanyl group): Epidural analgesia with levobupivacaine and fentanyl
TREATMENT
DOUBLE
Study Groups
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Group C (Control group)
pidural analgesia with levobupivacaine alone
levobupivacaine
The patients will receive 15 ml of 0.125% levobupivacaine.
Group D (Dexmedetomidine group)
Epidural analgesia with levobupivacaine and dexmedetomidine
levobupivacaine
The patients will receive 15 ml of 0.125% levobupivacaine.
Dexmedetomidine
The patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline.
Group F (Fentanyl group)
Epidural analgesia with levobupivacaine and fentanyl
levobupivacaine
The patients will receive 15 ml of 0.125% levobupivacaine.
Fentanyl
The patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline.
Interventions
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levobupivacaine
The patients will receive 15 ml of 0.125% levobupivacaine.
Dexmedetomidine
The patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline.
Fentanyl
The patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline.
Eligibility Criteria
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Inclusion Criteria
* Full term pregnancy.
Exclusion Criteria
* Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity hypersensitivity to levobupivacaine, dexmedetomidine or fentanyl, hemodynamic instability, severe aortic or mitral stenosis),
* Cardiac diseases
* Severe pre-eclampsia,
* Breech presentations
* Antepartum hemorrhage
* Cephalopelvic disproportion
* Body mass index ≥40 kg/m2.
21 Years
41 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Hend Mahmoud Moneeb El-shazly
Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Locations
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Tanta University Hospitals
Tanta, Gharbia Governorate, Egypt
Countries
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Other Identifiers
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33447/10/19
Identifier Type: -
Identifier Source: org_study_id
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