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).
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 suffering from severe postdural puncture headache (PDPH) are often bedridden and unable to care for themselves or their babies.The efficacy of epidural blood patch as a "gold standard" therapy is over-estimated by the earlier, poor quality studies. The prevalence of dural puncture during epidural anesthesia using current techniques ranges from 0.03 to 6% in the literature. Of these patients, 70 to 80% will suffer from moderate to severe PDPH. Avoidance of dural puncture is always the goal. However, complete avoidance is unlikely using current techniques of needle placement. This study proposes another method of prevention (i.e., reducing the gauge of the epidural needles if it is shown to be suitable for continuous infusion in adults). Most of the risk factors for developing PDPH cannot be changed (e.g., younger age, female sex, low body mass index, history of migraines). However, epidural needle gauge is a modifiable risk factor. Evidence suggests that the use of smaller gauge epidural needles, like spinal needles, have the potential to reduce the incidence and severity of PDPH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,081
Patients in the experimental group will receive a 23g 90cm adult length epidural catheter placed via a 19g Tuohy epidural needle (SIMS Portex, Hythe, UK). The 19g Tuohy needle is a standard 3½ inch length.
Patients in the control arm will receive a traditional large gauge (16g, 17g or 18g Tuohy or Hustead) epidural needle and a traditional epidural catheter. Two control needles and two control catheters will be designated apriori by each institution for use in the study.
British Columbia Women's Hospital and Health Centre
Vancouver, British Columbia, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
St. Joseph's Hospital
London, Ontario, Canada
Sunnybrook Health Sciences Centre at Women's College Hospital
Toronto, Ontario, Canada
Incidence of postdural puncture headache
Time frame: within the first 14 days of epidural placement
PDPH characteristics (quality, distribution, postural versus non-postural nature, associated symptoms)
Time frame: within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
Severity of pain related to PDPH
Time frame: within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
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
Duration of PDPH-related symptoms
Time frame: within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
Pain and pain relief (first and second stage labor analgesia following epidural placement and overall pain relief) as rated by the patient, compared between groups
Time frame: within 24 hours of epidural placement
Incidence of persistent PDPH symptoms between groups
Time frame: at 6 weeks post-epidural placement
Number and timing of epidural blood patches received, total number of epidural blood patches received until symptom resolution
Time frame: within the first 6 weeks of epidural placement
Risk of delayed block failure for continuous labour analgesia in patients receiving a 19g Tuohy epidural needle and 23g catheter
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Time frame: after first 30 minutes of successful initiation (requiring epidural reinsertion)
Risk of requiring use of an alternative method of anesthesia for operative delivery in patients receiving successful epidural initiation with a 19g Tuohy epidural needle and a 23g catheter
Time frame: during labour and delivery
Incidence of significant adverse events in each group
Time frame: up to 1 year post-epidural placement
Patient ratings of overall pain relief compared between groups
Time frame: during labour and delivery
Anesthesiologist satisfaction with the 19g Tuohy epidural needle and 23g catheter compared with traditional Tuohy type epidural needles and traditional catheters
Time frame: during labour and delivery