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

NCT07249814 | Completed

• 1 other identifier: 196
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Anesthesia for Cesarean Section

Keywords

Spinal Anesthesia; Hypotension; Hemodynamic Stability; Bupivacaine; Bolus Dose; Fractionated Dose; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Spinal block characteristics (sensory block level and duration, motor block duration, analgesia duration)

  Perioperative/Periprocedural

Study Arms (3)

Bolus bupivacaine (0.07 mg/cm)

ACTIVE COMPARATOR

Procedure: Bolus anesthesia

Fractionated bupivacaine (0.07 mg/cm)

EXPERIMENTAL

Procedure: Fractionated anesthesia

Fractionated bupivacaine (0.06 mg/cm)

ACTIVE COMPARATOR

Procedure: Fractionated anesthesia

Interventions

Fractionated anesthesia PROCEDURE

* 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).

Fractionated bupivacaine (0.06 mg/cm); Fractionated bupivacaine (0.07 mg/cm)

Bolus anesthesia PROCEDURE

• Group B: received a bolus administration of the total dose of 0.5% hyperbaric bupivacaine (0.07 mg/cm height)

Bolus bupivacaine (0.07 mg/cm)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bogomolets National Medical University: lead

Study Sites (1)

Kyiv Perinatal Center

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 25, 2025
• Study Start: June 30, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

UA (1)