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

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

Study Overview

• Status: Completed
• Conditions: Post-Dural Puncture Headache
• Intervention / Treatment: Drug: Restrictive fluid therapy; Drug: Liberal fluid therapy

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Restricted fluid therapy group; 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; 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
ACTIVE_COMPARATOR: Liberal fluid therapy group; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Tarek Abdelbarr, Professor, Head of obstetric anesthesia section in anesthesia department

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 30, 2018
• Primary Completion (ACTUAL): October 30, 2018
• Study Completion (ACTUAL): November 2, 2018

Study Registration Dates

• First Submitted: March 17, 2018
• First Submitted That Met QC Criteria: March 17, 2018
• First Posted (ACTUAL): March 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 18, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache
• Other Study ID Numbers: N-98-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No