Randomized Controlled Trial Examining the Effect of Small Versus Large Tuohy-type Epidural Needles on the Incidence and Severity of Postdural Puncture Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,081
- 试验地点
- 4
- 主要终点
- Incidence of postdural puncture headache
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
19g needle, 23g catheter
干预措施: 19g Tuohy-type epidural needle, 23g catheter (Device)
2
traditional =>18g needle
干预措施: => 18g Tuohy-type needle (Device)
结局指标
主要结局
Incidence of postdural puncture headache
时间窗: within the first 14 days of epidural placement
次要结局
- Duration of PDPH-related symptoms(within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement)
- 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(during labour and delivery)
- Severity of pain related to PDPH(within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement)
- Incidence of persistent PDPH symptoms between groups(at 6 weeks post-epidural placement)
- Patient ratings of overall pain relief compared between groups(during labour and delivery)
- 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(within 24 hours of epidural placement)
- Number and timing of epidural blood patches received, total number of epidural blood patches received until symptom resolution(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(after first 30 minutes of successful initiation (requiring epidural reinsertion))
- PDPH characteristics (quality, distribution, postural versus non-postural nature, associated symptoms)(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(within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement)
- Incidence of significant adverse events in each group(up to 1 year post-epidural placement)
- Anesthesiologist satisfaction with the 19g Tuohy epidural needle and 23g catheter compared with traditional Tuohy type epidural needles and traditional catheters(during labour and delivery)
研究者
Dr. Pamela Angle
Associate Professor, Director, Associate Scientist, Anesthesiologist
Sunnybrook Health Sciences Centre