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

NCT02859233 | Completed

• 1 other identifier: RC16_0031
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 4

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.

Conditions

Postdural Puncture Headache

Keywords

Spinal Puncture; Dural puncture; Nursing

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• The date of apparition of PDPH between day 0 and day 5

  between day 0 and day 5

Study Arms (2)

Control group

NO INTERVENTION

Routine advices about the interest of increase fluid after lumbar puncture to prevent PDPH will be transmitted: 2 liters will be provided to be drunk in 2 hours.

Interventional group

EXPERIMENTAL

Lack of hyperhydration : no particular advices will be transmitted about the interest of oral hyperhydration. 500 milliliters will be provided in case of thirst, according to patient's convenience.

Other: Lack of hyperhydration

Interventions

Lack of hyperhydration OTHER

Interventional group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient in need of dural puncture for diagnostic.
• Age between 18 and 60 years old.
• Patient willing to participate in the research.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (4)

Hospital centre CHD VENDEE

La Roche-sur-Yon, 85925, France

Location

Hospital centre LE MANS

Le Mans, 72037, France

Location

University Hospital NANTES

Nantes, 44093, France

Location

Hospital centre CORNOUAILLE

Quimper, 29107, France

Location

Related Publications (5)

• 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.

  PMID: 23771276 BACKGROUND

• 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.

  PMID: 26950232 BACKGROUND

• 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.

  PMID: 16116106 BACKGROUND

• 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.

  PMID: 3203698 BACKGROUND

• Cartron E, Volteau C, Leroy M, Voisine A, Dauvergne JE, Ballet C, Talarmin JP, Queau MA, Catinault M, Gazeau E, Haubertin C, Charreau R, Boutoille D. Oral fluid supplementation for the prevention of post-dural puncture headache: A noninferiority randomized controlled trial. PLoS One. 2025 Mar 12;20(3):e0319481. doi: 10.1371/journal.pone.0319481. eCollection 2025.

  PMID: 40073366 DERIVED

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Emmanuelle CARTRON

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: August 9, 2016
• Study Start: November 8, 2016
• Primary Completion: July 23, 2019
• Study Completion: July 23, 2019
• Last Updated: August 26, 2019

Record last verified: 2019-08

Locations

FR (4)