Two Fluid Strategies for Prevention of Post-dural Puncture Headache

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Post-Dural Puncture Headache

Treatments: Drug: Liberal fluid therapy; Drug: Restrictive fluid therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03475784

N-98-2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Restricted fluid therapy group

Experimental group

Description:

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.

Treatment:

Drug: Restrictive fluid therapy

Liberal fluid therapy group

Active Comparator group

Description:

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.

Treatment:

Drug: Liberal fluid therapy