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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07249814
Enrollment
99
Registered
2025-11-25
Start date
2024-06-30
Completion date
2025-06-15
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia for Cesarean Section

Keywords

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

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.

Interventions

PROCEDUREFractionated 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).

PROCEDUREBolus anesthesia

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

Sponsors

Bogomolets National Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Spinal block characteristics (sensory block level and duration, motor block duration, analgesia duration)Perioperative/PeriproceduralSpinal 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.

Countries

Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026