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 | — |