Two Fluid Strategies for Prevention of Post-dural Puncture Headache

Post-Dural Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475784
• Other study ID #: N-98-2017
• Status: Completed
• Phase: Phase 3
• Start date: March 30, 2018
• Est. completion date: November 2, 2018

Study information

• Verified date: August 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	heart rate	the number of heart beats per minute	24 hours
Secondary	postoperative nausea and vomiting	the number of patients who develop postoperative nausea and vomiting	24 hours