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

Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache: A Non-inferiority Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02859233
Acronym
PROPHYDRA
Enrollment
554
Registered
2016-08-09
Start date
2016-11-08
Completion date
2019-07-23
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postdural Puncture Headache

Keywords

Spinal Puncture, Dural puncture, Nursing

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.

Interventions

OTHERLack of hyperhydration

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of PDPH.At D5PDPH 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
The incidence of PDPH (in case of PDPH still present at D5).At D8PDPH 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

MeasureTime frame
The date of apparition of PDPH between day 0 and day 5between day 0 and day 5

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026