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Post-dural Puncture Headache - Needles and Biomarkers in CSF

NCT02384031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2019-04-08

No results posted yet for this study

Summary

Post-dural puncture headache (PDPH) is the most common complication following lumbar puncture (LP). The frequency varies widely depending on a number of factors, among which patient characteristics, case ascertainment, gauge and type of needle used are of significant importance. In 2001, Strupp et al. showed that over 12 % of 115 patients who were subjected to diagnostic lumbar puncture with a 22 gg (0.7 mm) atraumatic needle suffered post-dural puncture headache, while over 24 % of 115 who were given a lumbar puncture with a 22 gg traumatic needle suffered a headache. This finding provided the basis for an American recommendation to use a 22 gg atraumatic needle for diagnostic lumbar puncture. A later study with 58 patients has shown an even greater difference (36 % versus 3 % post-dural puncture headache) when an atraumatic needle is used. Despite these findings, European Neurologist continue to hold on to the cutting needle. Here the investigators propose a prospective randomized study design with double masking; neither patient nor evaluator of PDPH aware of the needle design used, and with an active ascertainment of the occurrence of PDPH in accordance with updated headache classification guidelines. The investigators also intend to investigate whether specific neuroinflammatory substances and metabolites (different outcome variables) in the cerebrospinal fluid (CSF) will affect the explanatory variable.

Conditions

  • Post-dural Puncture Headache

Interventions

DEVICE

Traumatic needle

Lumbar puncture is performed with a traumatic needle

DEVICE

Atraumatic needle

Lumbar puncture is performed with an atraumatic needle

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Nordlandssykehuset HF

    lead OTHER

Principal Investigators

  • Karl Alstadhaug, MD, PhD · Nordlandssykehuset HF

  • Francis Odeh, MD, PhD · Nordlandssykehuset HF

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Norway

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 NCT02384031 on ClinicalTrials.gov