Two Fluid Strategies for Prevention of Post-dural Puncture Headache

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Comparison of Two Fluid Strategies for Prevention of Post-dural Puncture Headache After Cesarean Delivery

Conditions
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Post-Dural Puncture Headache

Intervention / Treatment
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* Drug: Restrictive fluid therapy
* Drug: Liberal fluid therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restricted fluid therapy group<br>Restrictive fluid therapy: this group will not receive fluid pre-load, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2mL/Kg/hour. | Drug: Restrictive fluid therapy<br>* This group will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2 mL/Kg/hour.<br>* Other names: Restrictive fluids;|
| Active Comparator: Liberal fluid therapy group<br>Liberal fluid therapy: this group will receive fluid pre-load (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. | Drug: Liberal fluid therapy<br>* 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.<br>* Other names: Liberal fluids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-dural puncture headache | the number of patients who develop post-dural puncture headache defined as pain scale above 4 | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 48 hours | 
| heart rate | the number of heart beats per minute | 24 hours | 
| postoperative nausea and vomiting | the number of patients who develop postoperative nausea and vomiting | 24 hours |