Two Fluid Strategies for Prevention of Post-dural Puncture Headache

Phase 3

Completed

• Conditions: Post-Dural Puncture Headache
• Interventions: Drug: Restrictive fluid therapy; Drug: Liberal fluid therapy

• Registration Number: NCT03475784
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-03-17
• Study First Submitted QC: 2018-03-17
• Study First Posted: 2018-03-23
• Study Start: 2018-03-30
• Primary Completion: 2018-10-30
• Study Completion: 2018-11-02
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-18
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Full term
• Pregnant female
• Scheduled to elective cesarean delivery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restricted fluid therapy group	Restrictive fluid therapy	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.
Liberal fluid therapy group	Liberal fluid therapy	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.

Primary Outcome Measures

Name	Time	Method
Incidence of post-dural puncture headache	48 hours	the number of patients who develop post-dural puncture headache defined as pain scale above 4

Secondary Outcome Measures

Name	Time	Method
Wong-Baker faces pain scale	48 hours	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
postoperative nausea and vomiting	24 hours	the number of patients who develop postoperative nausea and vomiting
incidence of post-spinal hypotension	60 minutes	number of patients who develop hypotension defined as decrease of systolic blood pressure by more than 20% from the baseline reading after subarachnoid block
heart rate	24 hours	the number of heart beats per minute

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt