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. 2017 Apr 7;2017(4):CD010807. doi: 10.1002/14651858.CD010807.pub2

NCT00370604.

Trial name or title 'Effect of small versus large epidural needles on postdural puncture headache study'
Methods Allocation: randomized
 Endpoint classification: safety/efficacy study
 Intervention model: parallel assignment
 Masking: single‐blind (outcomes assessor)
 Primary purpose: prevention
Participants Inclusion criteria:
 ‐ American Society of Anesthesiologists status 1 to 2
 ‐ Must have provided written informed consent = or < 6 cm 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 anaesthesia 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
Age minimum: 18 years
Age maximum: N/A
Gender: female
Interventions Device: => 18 G Tuohy‐type needle
Device: 19 G Tuohy‐type epidural needle, 23 G catheter
Outcomes Incidence of post‐dural puncture headache (time frame: within the first 14 days of epidural placement)
Anaesthesiologist satisfaction with the 19 G Tuohy epidural needle and 23 G catheter compared with traditional Tuohy‐type epidural needles and traditional catheters (time frame: during labour and delivery)
Degree of dysfunction and disability related to PDPH symptoms (time frame: within first 14 days post‐epidural placement and, if necessary, up to 1 year post‐epidural placement)
Starting date June 2007
Contact information Pamela J Angle
Notes