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NCT Number: NCT06290583

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

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.

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Key information

Conditions

Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

South Valley University

Qina, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Bupivacaine

Drug

Spinal anesthesia with standard dose of bupivacaine

Other names: Intrathecal Bupivacaine

Prilocaine

Drug

Spinal anesthesia with 50 mg dose of Prilocaine.

Other names: Intrathecal prilocaine

Primary outcomes

  1. Maternal arterial blood pressure

    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

    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

Secondary outcomes

  1. Evaluation of duration of motor block

    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

    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).

  2. Total dose of ephedrine

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

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

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 4, 2024
Registry last updated
Mar 19, 2025

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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