Two Fluid Strategies for Prevention of Post-dural Puncture Headache

Cairo University100 enrolled

Overview

Postdural puncture headache (PDPH) is a common complication after cesarean delivery (CD). The role of peri-operative fluid therapy in prophylaxis against PDPH is unclear. The aim of this work is to compare restrictive versus liberal fluid therapy in prophylaxis against PDPH after CD

In this study, the investigators will compare restrictive fluid therapy and liberal fluid therapy in prophylaxis against postdural puncture headache. The restrictive group will not receive preoperative fluid loading, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2 mL/Kg/hour for hours. The Liberal group will receive preoperative fluid loading of 5 mL/Kg, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour, followed by postoperative crystalloids at rate of 6 mL/Kg/hour. Both groups will be compared regarding demographic data, total peri-operative fluids, incidence of postdural puncture headache, nausea, vomiting, and intraoperative hemodynamics (heart rate and systolic blood pressure) in addition to neonatal outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

100

Conditions

Post-Dural Puncture Headache

Interventions

Restrictive fluid therapyDRUG

This group will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2 mL/Kg/hour.

Liberal fluid therapyDRUG

This group will receive crystalloid preload of 5 mL/Kg, then will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 6 mL/Kg/hour.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Full term * Pregnant female * Scheduled to elective cesarean delivery Exclusion Criteria: * History of migraine headache * Hypertensive disorders of pregnancy * Cardiac morbidities, * Baseline systolic blood pressure \< 100 mmHg * Contraindication of regional anesthesia. * Patients with more than one single attempt for spinal block

Locations (1)

Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

Incidence of post-dural puncture headache

the number of patients who develop post-dural puncture headache defined as pain scale above 4

Time frame: 48 hours

Secondary Outcomes

incidence of post-spinal hypotension

number of patients who develop hypotension defined as decrease of systolic blood pressure by more than 20% from the baseline reading after subarachnoid block

Time frame: 60 minutes

Wong-Baker faces pain scale

Pain rating scale which is expressed by the patient starting from zero scale which corresponds to no pain, till scale 10 which corresponds to worst pain

Time frame: 48 hours

heart rate

the number of heart beats per minute

Time frame: 24 hours

postoperative nausea and vomiting

the number of patients who develop postoperative nausea and vomiting

Time frame: 24 hours

Data from ClinicalTrials.gov

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