Clinical trial NCT02859233: Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache
Official title: Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache: A Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postdural Puncture Headache
Keywords: Spinal Puncture
Dural puncture
Nursing
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of PDPH.
timeFrame: At D5
measure: The incidence of PDPH (in case of PDPH still present at D5).
timeFrame: At D8
Secondary outcomes:
measure: The date of apparition of PDPH between day 0 and day 5
timeFrame: between day 0 and day 5
Other outcomes:
Locations:
city: La Roche Sur Yon
country: France
facility: Hospital centre CHD VENDEE
city: Le Mans
country: France
facility: Hospital centre LE MANS
city: Nantes
country: France
facility: University Hospital NANTES
city: Quimper
country: France
facility: Hospital centre CORNOUAILLE
Study officials:
affiliation: Nantes University Hospital
name: Emmanuelle CARTRON
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
citation: Arevalo-Rodriguez I, Ciapponi A, Roque i Figuls M, Munoz L, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2016 Mar 7;3(3):CD009199. doi: 10.1002/14651858.CD009199.pub3.
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 [RETIRED]: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. doi: 10.1212/01.wnl.0000173034.96211.1b.
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. doi: 10.1007/BF00449906.