Hyperbaric Prilocaine 2% vs Hyperbaric Bupivacaine 0.5% in Caesarean Section

NCT06680167 | Completed Early Phase 1

• 1 other identifier: Soh-Med-15-10---6MS
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison between effects of hyperbaric bupivacaine 0.5% vs Hyperbaric prilocaine 2% in spinal anesthesia of women undergoing elective caesarean section such as onset time of sensory and motor block, duration of sensory and motor block, effects of maternal hemodynamics and expected side effects .

Conditions

Spinal Anesthesia

Keywords

onset time and duration of action; effects on maternal hemodynamics intraoperative and postoperative; evaluation of pain scores postoperatively

Outcome Measures

Primary Outcomes (2)

• Measurment of onset time and duration of sensory block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using pinprick sensation test in women undergoing caesarean section

  12 HOURS

• 2- Measurment of onset time and duration of motor block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using modified bromage scale in women undergoing caesarean section

  12 hours

Study Arms (2)

patients of group A will receive 60mg of hyperbaric prilocaine 2% for spinal anesthesia

ACTIVE COMPARATOR

Drug: spinal anesthesia (hyperbaric Prilocaine 2%)

patients of group B will receive 12.5mg heavy bupivacaine for spinal anesthesia

ACTIVE COMPARATOR

Drug: Spinal anesthesia (heavy bupivacaine 0.5%)

Interventions

Spinal anesthesia (heavy bupivacaine 0.5%) DRUG

12.5mg of Heavy bupivacaine 0.5% will be injected intrathecally for women undergoing elective caesarean section

patients of group B will receive 12.5mg heavy bupivacaine for spinal anesthesia

spinal anesthesia (hyperbaric Prilocaine 2%) DRUG

60mg of Hyperbaric Prilocaine 2% will be injected intrathecally for women undergoing elective caesarean section

patients of group A will receive 60mg of hyperbaric prilocaine 2% for spinal anesthesia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-45 years.
• Patients with uncomplicated pregnancies.
• American society of anesthesiologist (ASA) physical status I or II.
• Height between 155 cm and 175 cm.
• Written informed consent provided. -

You may not qualify if:

• Patients with known allergies to local anesthetics.
• Contraindications to intrathecal anesthesia (e.g., infection at the injection site and coagulopathy).
• Severe preeclampsia or eclampsia.
• Presence of significant comorbidities (e.g., uncontrolled diabetes, hypertension, renal or hepatic dysfunction).
• History of spinal surgery or significant spinal deformity.
• Patients who refuse to participate in the study -

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospitals

Sohag, Sohag Governorate, 82749, Egypt

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Comparative Study between Hyperbaric Prilocaine 2% versus Hyperbaric Bupivacaine 0.5% For Intrathecal Anesthesia in Caesarean Section

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: October 9, 2024
• Primary Completion: November 5, 2025
• Study Completion: December 24, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)