Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache

Postdural Puncture Headache Clinical Trial

— PROPHYDRA  

Official title:

Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache: A Non-inferiority Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859233
• Other study ID #: RC16_0031
• Status: Completed
• Phase: N/A
• Start date: November 8, 2016
• Est. completion date: July 23, 2019

Study information

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

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: July 23, 2019
• Est. primary completion date: July 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache
• Wounds and Injuries

Intervention

Other:
• Lack of hyperhydration

Locations

Country	Name	City	State
France	Hospital centre CHD VENDEE	La Roche Sur Yon
France	Hospital centre LE MANS	Le Mans
France	University Hospital NANTES	Nantes
France	Hospital centre CORNOUAILLE	Quimper

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (4)

Arevalo-Rodriguez I, Ciapponi A, Roqué i Figuls M, Muñoz L, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2016 Mar 7;3:CD009199. doi: 10.1002/14651858.CD009199.pub3. Review. — View Citation

Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. — View Citation

Dieterich M, Brandt T. Incidence of post-lumbar puncture headache is independent of daily fluid intake. Eur Arch Psychiatry Neurol Sci. 1988;237(4):194-6. — View Citation

Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of PDPH.	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	At D5
Primary	The incidence of PDPH (in case of PDPH still present at D5).	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.	At D8
Secondary	The date of apparition of PDPH between day 0 and day 5		between day 0 and day 5