Two Fluid Strategies for Prevention of Post-dural Puncture Headache
Primary Purpose
Post-Dural Puncture Headache
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Restrictive fluid therapy
Liberal fluid therapy
Sponsored by
About this trial
This is an interventional prevention trial for Post-Dural Puncture Headache
Eligibility Criteria
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
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Restricted fluid therapy group
Liberal fluid therapy group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Incidence of post-dural puncture headache
the number of patients who develop post-dural puncture headache defined as pain scale above 4
Secondary Outcome Measures
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
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
heart rate
the number of heart beats per minute
postoperative nausea and vomiting
the number of patients who develop postoperative nausea and vomiting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03475784
Brief Title
Two Fluid Strategies for Prevention of Post-dural Puncture Headache
Official Title
Comparison of Two Fluid Strategies for Prevention of Post-dural Puncture Headache After Cesarean Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
November 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Restricted fluid therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Liberal fluid therapy group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Restrictive fluid therapy
Other Intervention Name(s)
Restrictive fluids
Intervention Description
This group will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2 mL/Kg/hour.
Intervention Type
Drug
Intervention Name(s)
Liberal fluid therapy
Other Intervention Name(s)
Liberal fluids
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of post-dural puncture headache
Description
the number of patients who develop post-dural puncture headache defined as pain scale above 4
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
incidence of post-spinal hypotension
Description
number of patients who develop hypotension defined as decrease of systolic blood pressure by more than 20% from the baseline reading after subarachnoid block
Time Frame
60 minutes
Title
Wong-Baker faces pain scale
Description
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
Time Frame
48 hours
Title
heart rate
Description
the number of heart beats per minute
Time Frame
24 hours
Title
postoperative nausea and vomiting
Description
the number of patients who develop postoperative nausea and vomiting
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Abdelbarr, Professor
Organizational Affiliation
Head of obstetric anesthesia section in anesthesia department
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Two Fluid Strategies for Prevention of Post-dural Puncture Headache
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