Skip to main content
OpenTrials
Completed

NCT Number: NCT03080610

The Occurrence of Post Dural Puncture Headache After Epidural Blood Patch

Spinal anesthesia is commonly used for cesarean section.However, the procedure is still have some adverse events such as high spinal block, nerve injuries or postdural puncture headache (PDPH).This is a potential complication of neuraxial anesthesia in clinical practice.

The investigators are curious regarding factors determining the incidence of postdural puncture headache in parturients undergoing cesarean section after epidural blood patch.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Observational

Primary location

Pattrapun Wongsripuemtet, Bangkok Noi, Bangkok, Thailand

Loading trial locations.

About this study

Currently, spinal anesthesia is commonly used for cesarean section in many institutes, since it is a safe technique for both mother and child, with high satisfaction of obstetricians and their colleagues. Bloom, et al. claimed that there was 37,142 women underwent cesarean section in 2002 where 94% was under regional anesthesia, as 40% spinal, 42% epidural and 12% combined spinal and epidural anesthesia.

However, the procedure is inevitable to have some adverse events such as high spinal block, nerve injuries or postdural puncture headache (PDPH) . The PDPH is caused by accidental dura puncture resulting in continuous cerebrospinal fluid (CSF) leakage and gradual intracranial pressure reduction. This is a potential complication of neuraxial anesthesia in clinical practice. The needle characteristics as bevel orientation, stylet reinsertion, an approach, multiple insertion, and operator experience, patient age, history of previous PDPH, body mass index (BMI) > 35 are some responsible factors for the incidence. Chan et al. revealed that amongst 65,348 parturients, the occurence of PDPH was 1.1-1.9%, while Bloom et al. proposed his number as 0.4%. Interestingly, an obstetric meta-analysis showed an incidence of 1.5-11%, caused by spinal needle.

The PDPH is defined as a symptom of severe headache that appears within 7 days following a lumbar puncture. It may be accompanied by other manifestations such as tinnitus, hypoacusis, photophobia, nausea, or neck stiffness. Actually, it can resolve within 1 week or 48 hour after a treatment of blood patch. Other additional treatments include bed rest, analgesics, increase fluid intake, or caffeine containing beverages. In a severe case, a retractable pain might have a good response to intravenous caffeine and epidural blood patch (EBP). Though treatments of PDPH include both pharmacologic and non-pharmacologic regimens, Cochrane review concluded that the EBP was more effective than any other conservative treatments. As a result, the investigators are curious regarding factors determining the incidence of postdural puncture headache in parturients undergoing cesarean section after epidural blood patch.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • parturient after received spinal block for cesarean section who have post Dural puncture headache and received epidural blood patch in Siriraj hospital during 1 January 2006 to 30 December 2015

Exclusion criteria

  • patient who diagnosed post Dural puncture headache from accidental Dural puncture from epidural needle or received combine spinal epidural anesthesia

Treatment and study plan

Primary outcomes

  1. The Occurrence of Post Dural Puncture Headache after Epidural Blood Patch

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Official study title

Factors Influencing the Occurrence of Post Dural Puncture Headache in Patients Undergoing Cesarean Section After Epidural Blood Patch

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Mar 15, 2017
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.