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

South Valley University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Interventions

BupivacaineDRUG

Spinal anesthesia with standard dose of bupivacaine

PrilocaineDRUG

Spinal anesthesia with 50 mg dose of Prilocaine.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

South Valley University

Qina, Egypt

Outcomes

Primary Outcomes

Maternal arterial blood pressure

Noninvasive blood pressure will be measured at selected time frame.. Hypotension will be defined as a decrease of systolic blood pressure of at least 20% from baseline. Upon its occurrence, and/or appearance of nausea and dizziness, treatment will be immediately with ephedrine 5mg/ dose

Time frame: at base line before induction and every 3 minute during the first 15 min after spinal then every 5 mins until the end of surgery and every 1 hour postoperatively for 6 hours

Secondary Outcomes

Evaluation of duration of motor block

the time to motor block regression (duration of motor block), defined as the time between complete block (score 1) after induction of prilocaine or bupivacaine and no motor block (score 6) on the Modified Bromage scale (1, complete motor block; 2, almost complete motor block, ability to move the feet only; 3, ability to move the knees; 4, ability to raise the leg but unable to keep it raised; 5, ability to keep the leg raised for 10 s; 6, no weakness).

Time frame: will be assessed before skin incision and every 15 min intervals until the end of surgery and then at 30-min intervals until its complete regression

Total dose of ephedrine

When hypotension occurred postspinal ephedrine 5mg per dose will be given to restore blood pressure to 90% of its baseline value.

Time frame: From beginning of administration of spinal anesthesia until complete regression of motor blockade

Data from ClinicalTrials.gov

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