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Study aim:
Effect of pre-spinal anesthesia intravenous fluid therapy on the incidence of post-dural puncture headache and hemodynamic disturbances in cesarean section patients
Design:
• Type: Single-blind randomized controlled trial (RCT)
• Groups: Two groups (Intervention vs. Control)
• Randomization: Block randomization or random table method
• Blinding: Patients are blinded to group assignment. IV fluids are prepared in identical, coded bags. The anesthesiologist and outcome assessors are also blinded to group allocation.
Settings and conduct:
• Setting: Amir-al-Momenin Hospital, labor ward and operating room
• Methods:
• Patients are evaluated preoperatively and provide informed consent
• Intervention group: receives IV crystalloid [10–15 ml/kg] prior to spinal anesthesia
• Control group: receives fluids only as clinically indicated
• Outcomes: Hemodynamic parameters recorded in the operating room; post-dural puncture headache assessed at 24, 48 hours, and day 3 postoperatively
Participants/Inclusion and exclusion criteria:
• Pregnant women scheduled for cesarean section, aged 18–45 years
• ASA physical status I–II
• Provided informed consent for participation
Intervention groups:
1. Intervention group: Receive intravenous crystalloid [10–15 ml/kg] over 15–20 minutes before spinal anesthesia.
2. Control group: No prophylactic preloading; fluids are given only as clinically indicated.
Main outcome variables:
• Primary outcome: Incidence of PDPH at 24, 48 hours, and day 3 postoperatively, assessed by patient report and VAS (0–10).
• Secondary outcome: Hemodynamic disturbances, defined as ≥20% drop in systolic BP or MAP <65 mmHg, and requirement for vasopressors, recorded intraoperatively.