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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus bupivacaine (0.07 mg/cm) | Active Comparator |
| |
| Fractionated bupivacaine (0.07 mg/cm) | Experimental |
| |
| Fractionated bupivacaine (0.06 mg/cm) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractionated anesthesia | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyiv Perinatal Center | Kyiv | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41947048 | Derived | 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. |
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| Bolus anesthesia | Procedure | • Group B: received a bolus administration of the total dose of 0.5% hyperbaric bupivacaine (0.07 mg/cm height) |
|
| Perioperative/Periprocedural |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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