Comparison of Fractionated Versus Bolus Administration of Different Doses of Hyperbaric Bupivacaine Combined With Opioids in Spinal Anesthesia for Caesarean Section

Comparison of Fractionated Versus Bolus Administration of Different Doses of Hyperbaric Bupivacaine Combined With Opioids in Spinal Anesthesia for Caesarean Section - A Prospective, Randomized, Single Blind Clinical Trial

This study aimed to compare the effectiveness and safety of fractionated versus bolus administration of different doses of hyperbaric bupivacaine (0.06 and 0.07 mg/cm height) combined with opioids in spinal anesthesia for cesarean section, with detailed evaluation of maternal hemodynamic effects, block characteristics and side effects.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia for Cesarean Section
• Intervention / Treatment: Procedure: Bolus anesthesia; Procedure: Fractionated anesthesia

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • Kyiv Perinatal Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• singleton full-term pregnancy scheduled for cesarean section under spinal anesthesia
• ASA physical status II-III
• age 18-50 years
• height from 140 to 180 cm
• body weight from 40 to 130 kg

Exclusion Criteria:

• patient refusal
• contraindications to spinal anesthesia
• allergy to amide-type local anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bolus bupivacaine (0.07 mg/cm)	Procedure: Bolus anesthesia; • Group B: received a bolus administration of the total dose of 0.5% hyperbaric bupivacaine (0.07 mg/cm height)
Experimental: Fractionated bupivacaine (0.07 mg/cm)	Procedure: Fractionated anesthesia; Group F7: received a fractionated administration of bupivacaine (0.07 mg/cm);; Group F6: received a fractionated administration of the reduced dose of bupivacaine (0.06 mg/cm).
Active Comparator: Fractionated bupivacaine (0.06 mg/cm)	Procedure: Fractionated anesthesia; Group F7: received a fractionated administration of bupivacaine (0.07 mg/cm);; Group F6: received a fractionated administration of the reduced dose of bupivacaine (0.06 mg/cm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic Stability (systolic, diastolic and mean arterial pressure, heart rate)	Hemodynamic parameters were recorded every 2 minutes for 10 minutes, then every 5 minutes until 30 minutes, then every 15 minutes until surgery completion.	Perioperative/Periprocedural - before spinal anesthesia and then during the cesarean section until its completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal block characteristics (sensory block level and duration, motor block duration, analgesia duration)	Spinal block characteristics were assessed every minute for 5 minutes, then every 5 minutes until peak effect, then every 30 minutes until sensory regression to L1 dermatome and motor block regression to Bromage 0. Sensory block was assessed using pin-prick method at the midaxillary line bilaterally. Motor block was evaluated using the modified Bromage scale (0 = full motor function, 3 = complete motor block). Postoperative pain was assessed using numeric rating scale (NRS) every 30 minutes for 2 hours, then hourly for 8 hours.	Perioperative/Periprocedural

Collaborators and Investigators

• Sponsor: Bogomolets National Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2024
• Primary Completion (Actual): June 15, 2025
• Study Completion (Actual): June 15, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hypotension; Bupivacaine; Cesarean Section; Spinal Anesthesia; Hemodynamic Stability; Fractionated Dose; Bolus Dose
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: 196

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No