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

Spinal Anesthetics Causing Adverse Effects in Therapeutic Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06290583
• Other study ID #: Prilocaine in cesarean section
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: South Valley University
• Contact: Mohamed G Ahmed, MD
• Phone: 01003072269
• Email: zeinab5aton[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Intervention

Drug:
• Bupivacaine
Spinal anesthesia with standard dose of bupivacaine
• Prilocaine
Spinal anesthesia with 50 mg dose of Prilocaine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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).	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
Secondary	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.	From beginning of administration of spinal anesthesia until complete regression of motor blockade