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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02859233
Other study ID # RC16_0031
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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