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

NCT02859233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 554

Last updated 2019-08-26

No results posted yet for this study

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

Interventions

OTHER

Lack of hyperhydration

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Emmanuelle CARTRON · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-08
Primary Completion
2019-07-23
Completion
2019-07-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02859233 on ClinicalTrials.gov