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Completed

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.

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Key information

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

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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

Lack of hyperhydration

Other

Primary outcomes

  1. 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

  2. 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

  1. 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.

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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.

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