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NCT Number: NCT07249814

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

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.

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Key information

Conditions

Spinal Anesthesia for Cesarean Section Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kyiv Perinatal Center

Kyiv, Ukraine

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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).

Bolus anesthesia

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

Primary outcomes

  1. Hemodynamic Stability (systolic, diastolic and mean arterial pressure, heart rate)

    Time frame: Perioperative/Periprocedural - before spinal anesthesia and then during the cesarean section until its completion

    Hemodynamic parameters were recorded every 2 minutes for 10 minutes, then every 5 minutes until 30 minutes, then every 15 minutes until surgery completion.

Secondary outcomes

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

    Time frame: Perioperative/Periprocedural

    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.

Sponsors and collaborators

Lead sponsor

Bogomolets National Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Nov 25, 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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