Comparing the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section

NCT ID: NCT06290583

Last Updated: 2025-03-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-21

Study Completion Date

2025-01-01

Brief Summary

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one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes.

Detailed Description

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Conditions

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Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group B

Patients will be given spinal anesthesia with bupivacaine (10 mg) added to morphine (100 microgram) and will be diluted with 0.9% saline to the 3 ml final volume to be injected.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Spinal anesthesia with standard dose of bupivacaine

Group P

Patients will be given spinal anesthesia with prilocaine (50 mg) added to morphine (100 microgram) and will be diluted with 0.9% saline to the 3 ml final volume to be injected.

Group Type ACTIVE_COMPARATOR

Prilocaine

Intervention Type DRUG

Spinal anesthesia with 50 mg dose of Prilocaine.

Interventions

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Bupivacaine

Spinal anesthesia with standard dose of bupivacaine

Intervention Type DRUG

Prilocaine

Spinal anesthesia with 50 mg dose of Prilocaine.

Intervention Type DRUG

Other Intervention Names

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Intrathecal Bupivacaine Intrathecal prilocaine

Eligibility Criteria

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Inclusion Criteria

* Pregnant \>36 weeks singleton baby
* American Society of Anesthesiologists (ASA) physical status 2
* Age : between 18 years old and 35 years old

Exclusion Criteria

* Pregnant women with cardiac disease and history of psychiatric illness
* Pregnant women who received spinal anesthesia and converted to general anesthesia
* Women who have sensitivity to local anesthetics,
* Women who have Eclampsia, abruption placenta or placenta previa
* Women who have coagulopathy, thrombocytopenia with platelet count less than 80,000/cm3, myasthenia
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Gaber Ahmed

Lecturer in anesthesiology, intensive care and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed G Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer in anesthesiology, intensive care and pain management, South Valley University

Locations

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South Valley University

Qina, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Prilocaine in cesarean section

Identifier Type: -

Identifier Source: org_study_id

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