Spinal Anesthesia for Cesarean SectionNCT07249814
Comparison of Fractionated Versus Bolus Administration of Different Doses of Hyperbaric Bupivacaine Combined With Opioids in Spinal Anesthesia for Caesarean Section
A study testing Fractionated anesthesia and Bolus anesthesia in people with Spinal Anesthesia for Cesarean Section, run by Bogomolets National Medical University at 1 site in Ukraine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Spinal Anesthesia for Cesarean Section
- What is being tested?
- Fractionated anesthesia and Bolus anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUkraine
- Study dates
- 30 Jun 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- patient refusal
- contraindications to spinal anesthesia
- allergy to amide-type local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Fractionated anesthesia, Bolus anesthesia
- Keywords
- Spinal Anesthesia, Hypotension, Hemodynamic Stability, Bupivacaine, Bolus Dose, Fractionated Dose, Cesarean Section
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated anesthesiaProcedure or surgery
- 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 anesthesiaProcedure or surgery
- Group B: received a bolus administration of the total dose of 0.5% hyperbaric bupivacaine (0.07 mg/cm height)
| Study group | Role | What they receive |
|---|---|---|
| Bolus bupivacaine (0.07 mg/cm) | Active comparator | Not described Receives: Procedure: Bolus anesthesia |
| Fractionated bupivacaine (0.07 mg/cm) | Experimental | Not described Receives: Procedure: Fractionated anesthesia |
| Fractionated bupivacaine (0.06 mg/cm) | Active comparator | Not described Receives: Procedure: Fractionated anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start30 Jun 2024
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Anesthesia for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bogomolets National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kateryna Bielka, Bogomolets National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249814
- Sponsor's protocol ID
- 196
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kuchyn I, Bielka K, Nimkovych R, Sirenko I. Comparison of fractionated versus bolus administration of different doses of hyperbaric bupivacaine combined with opioids in spinal anesthesia for caesarean section - a prospective, randomized, participant-blind clinical trial. BMC Anesthesiol. 2026 Apr 7;26(1):305. doi: 10.1186/s12871-026-03813-z.
PubMed 41947048
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07249814
- Acronym / sponsor ID
- 196
- Conditions
- Spinal Anesthesia for Cesarean Section
- Keywords
- Spinal Anesthesia, Hypotension, Hemodynamic Stability, Bupivacaine, Bolus Dose, Fractionated Dose, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Bogomolets National Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- patient refusal
- contraindications to spinal anesthesia
- allergy to amide-type local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Fractionated bupivacaine (0.06 mg/cm), Fractionated bupivacaine (0.07 mg/cm) |
| Bolus anesthesia• Group B: received a bolus administration of the total dose of 0.5% hyperbaric bupivacaine (0.07 mg/cm height) | Procedure or surgery | Bolus bupivacaine (0.07 mg/cm) |
Primary outcome
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.
1 secondary outcome
Spinal block characteristics (sensory block level and duration, motor block duration, analgesia duration)
Time frame: Perioperative/Periprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Derived from this study: PubMed 41947048Kuchyn I, Bielka K, Nimkovych R, Sirenko I. Comparison of fractionated versus bolus administration of different doses of hyperbaric bupivacaine combined with opioids in spinal anesthesia for caesarean section - a prospective, randomized, participant-blind clinical trial. BMC Anesthesiol. 2026 Apr 7;26(1):305. doi: 10.1186/s12871-026-03813-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractionated anesthesia and Bolus anesthesia in people with Spinal Anesthesia for Cesarean Section, run by Bogomolets National Medical University at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07249814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.