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Completed

NCT Number: NCT03475784

Two Fluid Strategies for Prevention of Post-dural Puncture Headache

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

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Key information

Conditions

Post-Dural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restrictive fluid therapy

Drug

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

Other names: Restrictive fluids

Liberal fluid therapy

Drug

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.

Other names: Liberal fluids

Primary outcomes

  1. Incidence of post-dural puncture headache

    Time frame: 48 hours

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

Secondary outcomes

  1. incidence of post-spinal hypotension

    Time frame: 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

  2. Wong-Baker faces pain scale

    Time frame: 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

  3. heart rate

    Time frame: 24 hours

    the number of heart beats per minute

  4. postoperative nausea and vomiting

    Time frame: 24 hours

    the number of patients who develop postoperative nausea and vomiting

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 23, 2018
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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