WithdrawnPhase 2/3

Epidural Blood Patch on the Resolution of Postdural Puncture Headache (PDPH)

Stopped: Lack of subject population for PI

United States0Started 2006-09

Plain-language summary

The purpose of this study is to address the question, "What is the volume of blood for injection at epidural blood patch that most effectively relieves post-dural puncture headache?"

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Obstetric patients aged 18 or more years * Post-dural puncture headache (PDPH) after a confirmed or likely unintentional dural puncture with an epidural needle. PDPH is defined as " A headache with clear postural characteristics (onset or significant exacerbation when erect and relieved or significantly diminished by lying flat). The diagnosis is supported by distribution in the frontal or occipital region, with associated neck ache." * Medically suitable for and have consented to epidural blood patch (EBP) for treatment of PDPH Exclusion Criteria: * Previous epidural blood patch (EBP) related to the same unintentionl dural puncture (including prophylactic EBP) * EBP to be performed more than 5 days after the unintentional dural puncture. * History of significant low or radicular back pain (requiring treatment) during pregnancy * Women in whom a further dural puncture occurs at the time of epidural needle insertion for the EBP * Diagnosis other than PDPH subsequently confirmed.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The site of headache

Timeframe: After epidural puncture

Associated symptoms of headache

Timeframe: after epidural puncture

The severity of and the degree of functional impairment from the post-dural puncture headache

Timeframe: after epidural puncture

The back discomfort experienced before, during, and after injection of blood

Timeframe: before, during and after injection of blood

Complete or partial success at relieving headache

Timeframe: After blood patch

Trial details

NCT IDNCT00373074

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-07

View on ClinicalTrials.gov More Post-Lumbar Puncture Headache trials

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The site of headache

Timeframe: After epidural puncture

Associated symptoms of headache

Timeframe: after epidural puncture

The severity of and the degree of functional impairment from the post-dural puncture headache

Timeframe: after epidural puncture

The back discomfort experienced before, during, and after injection of blood

Timeframe: before, during and after injection of blood

Complete or partial success at relieving headache

Timeframe: After blood patch