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Two Fluid Strategies for Prevention of Post-dural Puncture Headache

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03475784
Enrollment
100
Registered
2018-03-23
Start date
2018-03-30
Completion date
2018-11-02
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Dural Puncture Headache

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.

Interventions

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

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of post-dural puncture headache48 hoursthe number of patients who develop post-dural puncture headache defined as pain scale above 4

Secondary

MeasureTime frameDescription
incidence of post-spinal hypotension60 minutesnumber of patients who develop hypotension defined as decrease of systolic blood pressure by more than 20% from the baseline reading after subarachnoid block
Wong-Baker faces pain scale48 hoursPain 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
heart rate24 hoursthe number of heart beats per minute
postoperative nausea and vomiting24 hoursthe number of patients who develop postoperative nausea and vomiting

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026