CompletedNot Applicable

Effect of Small Versus Large Epidural Needles on Postdural Puncture Headache Study

Canada1,081 participantsStarted 2007-06

Plain-language summary

The purpose of this study is to determine the effect of 19g versus =\>18g traditional Tuohy-type epidural needles on the incidence and severity of postdural puncture headache (PDPH).

Who can participate

Age range

18 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: * American Society of Anesthesiologists status 1 to 2 * Must have provided written informed consent = or \< 6cm cervical dilation * Fetus 37 to 42 weeks gestation * Must be able to read and write English well enough to provide written informed consent Exclusion Criteria: * BMI = or \> 40 * Multiple gestation pregnancy * Known contraindications to use of epidural analgesia * Pregnancy-induced hypertension * Investigator concern for maternal or neonatal welfare * Receipt of spinal or epidural anesthesia within 14 days of labour epidural request * Women with chronic headaches (defined as headaches that occur 15 or more days per month for more than 3 months) * Already participated in study * History of narcotic abuse

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

Incidence of postdural puncture headache

Timeframe: within the first 14 days of epidural placement

Trial details

NCT IDNCT00370604

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-12

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