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

NCT ID: NCT07249814

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2025-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Anesthesia for Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Bolus bupivacaine (0.07 mg/cm)

Group Type ACTIVE_COMPARATOR

Bolus anesthesia

Intervention Type PROCEDURE

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

Fractionated bupivacaine (0.07 mg/cm)

Group Type EXPERIMENTAL

Fractionated anesthesia

Intervention Type 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)

Group Type ACTIVE_COMPARATOR

Fractionated anesthesia

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Bolus anesthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bogomolets National Medical University

OTHER

Sponsor Role lead

Responsible Party

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Kateryna Bielka

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kyiv Perinatal Center

Kyiv, , Ukraine

Site Status

Countries

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Ukraine

Other Identifiers

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196

Identifier Type: -

Identifier Source: org_study_id

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