Status:
COMPLETED
Effect of Small Versus Large Epidural Needles on Postdural Puncture Headache Study
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Canadian Anesthesiologists' Society
Conditions:
Post-Dural Puncture Headache
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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).
Detailed Description
A headache is the most significant complication of dural puncture during epidural placement. This complication leads to longer hospital stays and many repeated visits to hospital for management. Women...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
1081 Patients enrolled
Trial Details
Trial ID
NCT00370604
Start Date
June 1 2007
End Date
December 1 2009
Last Update
June 9 2022
Active Locations (4)
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1
British Columbia Women's Hospital and Health Centre
Vancouver, British Columbia, Canada, V6H 3N1
2
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
3
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
4
Sunnybrook Health Sciences Centre at Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2