Clinical Trial: Effect of Small Versus Large Epidural Needles on Postdural Puncture Headache Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Trial Examining the Effect of Small Versus Large Tuohy-type Epidural Needles on the Incidence and Severity of Postdural Puncture Headache

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 Summary: 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.
Sponsor: Sunnybrook Health Sciences Centre

Current Primary Outcome: Incidence of postdural puncture headache [ Time Frame: within the first 14 days of epidural placement ]

Original Primary Outcome: Incidence of post dural puncture headache diagnosed within the first 14 days of epidural placement

Current Secondary Outcome:

  • 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 [ 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 ]


Original Secondary Outcome:

  • PDPH characteristics (quality, distribution, postural versus non-postural nature, associated symptoms)
  • Severity of pain related to PDPH
  • Degree of dysfunction related to PDPH symptoms
  • Duration of PDPH-related symptoms
  • Pain and pain relief (first and second stage labor analgesia following epidural placement and overall pain relief) will be rated by the patient within 24 hours of delivery
  • Incidence of persistent PDPH symptoms at 6 weeks between groups
  • Number and timing of epidural blood patches received within the first 6 weeks of epidural placement, total number of epidural blood patches received until symptom resolution
  • Details related to epidural blood patches (blood volume, pain relief)
  • Drug therapies used to treat PDPH
  • Pain and pain relief (first and second stage labor analgesia following epidural placement and overall pain relief) as rated by the patient within 24 hours of delivery


Information By: Sunnybrook Health Sciences Centre

Dates:
Date Received: August 29, 2006
Date Started: June 2007
Date Completion:
Last Updated: June 19, 2015
Last Verified: June 2015