Two Fluid Strategies for Prevention of Post-dural Puncture Headache

NCT03475784 | Completed Phase 3 DMC

• 1 other identifier: N-98-2017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• incidence of post-spinal hypotension

  60 minutes

• Wong-Baker faces pain scale

  48 hours

• heart rate

  24 hours

• postoperative nausea and vomiting

  24 hours

Study Arms (2)

Restricted fluid therapy group

EXPERIMENTAL

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

Liberal fluid therapy group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Restrictive fluids

Restricted fluid therapy group

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.

Also known as: Liberal fluids

Liberal fluid therapy group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Full term
• Pregnant female
• Scheduled to elective cesarean delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tarek Abdelbarr, Professor

  Head of obstetric anesthesia section in anesthesia department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 17, 2018
• First Posted: March 23, 2018
• Study Start: March 30, 2018
• Primary Completion: October 30, 2018
• Study Completion: November 2, 2018
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)