NCT Number: NCT02859233
Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache
Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.
For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice, in the standard patient care.
The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH.
The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Hospital centre CHD VENDEE, La Roche-sur-Yon, France
About this study
Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.
For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice by non-inferiority study, in the standard patient care.
The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH. It will be evaluated on the occurrence of PDPH in both of the two groups The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patient in need of dural puncture for diagnostic.
- Age between 18 and 60 years old.
- Patient willing to participate in the research.
Exclusion criteria
- Pregnancy.
- Contraindication for increased oral fluid intake.
- Previous dural puncture within 5 day prior enrollment.
- Parenteral fluid intake superior at 266 ml for 2 hours after dural puncture (1000 ml per day).
- Enteral artificial feeding.
- Patient not in capacity to understand correctly French.
- Patient whose cannot be followed correctly by phone.
- Patient refusing to participate in the study.
Treatment and study plan
Primary outcomes
-
The incidence of PDPH.
Time frame: At D5
PDPH will be observed on the 5th day (D5) after the lumbar puncture (D0). If PDPH is still present on the 5th day, the patient continues to be followed until the 8th day after the lumbar puncture
-
The incidence of PDPH (in case of PDPH still present at D5).
Time frame: At D8
PDPH will be observed also on the 8th day (D8) after the lumbar puncture (D0). , if PDPH was still present on the 5th day, to confirm the diagnosis of PDPH.
Secondary outcomes
-
The date of apparition of PDPH between day 0 and day 5
Time frame: between day 0 and day 5
Sponsors and collaborators
Lead sponsor
Nantes University Hospital
Other
Registry information
Official study title
Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache: A Non-inferiority Randomized Controlled Trial
Acronym: PROPHYDRA
Important dates
- Study start
- 2016
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Aug 9, 2016
- Registry last updated
- Aug 26, 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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Effect of Coffee on Postdural Puncture Headache After Cesarean Section
NCT07410741
Brain Diseases, Central Nervous System Diseases
Ankara, Turkey (Türkiye)
View Trial DetailsPlasma Rich Fibrin Epidural Injection by Racz Catheter Versus Epidural Blood Patch in Postdural Puncture Headache
NCT06790745
Brain Diseases, Central Nervous System Diseases
Tanta, El-Gharbia, Egypt
View Trial DetailsPlasma Rich Fibrin Epidural Injection by Racz Catheter in Postdural Puncture Headache Guided Optic Nerve Sheath Diameter
NCT06790758
Brain Diseases, Central Nervous System Diseases
Tanta, El-Gharbia, Egypt
View Trial DetailsOndansetron and Dexamethasone for Prevention of PDPH, Nausea, and Vomiting
NCT07068230
Brain Diseases, Central Nervous System Diseases
Minya, Minya Governorate, Egypt
View Trial Details