Predicting Spinal Failure With Blunt Needle Pinprick Sensory Testing
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of participants with spinal failure
研究概览
简要总结
This will be a prospective, observational, single-center study to evaluate the accuracy of sensory testing by blunt 16-gauge plastic cannula during the 15 minutes after spinal injection for predicting spinal failure. While previous studies assessed the minimal sensory level required for painless cesarean delivery at skin incision or delivery, no studies have assessed the accuracy of sensory testing at an earlier time point.
详细描述
Primary Objective:
- Evaluate the accuracy of sensory testing with blunt plastic 16-gauge cannula during the 15 minutes after spinal injection for predicting spinal failure. Cephalad sensory dermatomal levels will be assessed at 1 (t1), 3 (t3), 5 (t5), 7 (t7), 9 (t9), 11 (t11), 13 (t13), and 15 (t15) minutes after intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg morphine (study solution). Spinal failure, which is defined as inability to achieve a T4 level to pinprick by the 15-minute timepoint or intraoperative pain (VAS > 0) requiring treatment
Secondary Objectives:
- Conversion to another anesthetic technique (general anesthesia or activation of the epidural catheter)
- Inadequate anesthesia (analgesic supplementation with ketamine, > 20 mg propofol, > 2 mg midazolam, > 10 mg parental morphine equivalents, or intraperitoneal chloroprocaine).
- Patient satisfaction upon arrival to the postanesthesia care unit, rated on a 1-5 Likert scale
A sample size calculation
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing cesarean delivery under spinal or combined spinal epidural anesthesia
- •BMI between 20 and 40 kg/m2
- •Height between 5 feet 2 inches and 5 feet 10 inches.
- •English and non-English speaking patients, if interpretive services are available
排除标准
- •Patient refusal
- •Contraindications to neuraxial anesthesia (coagulopathy, CNS pathology, infection at site of needle puncture)
- •Allergy to any study medications
- •Use of epidural anesthesia
- •Emergency (red) cesarean delivery
- •Conditions that impact dermatomal sensory testing including spinal cord injury with sensory deficits and abdominoplasty
- •Prison inmates
- •Decisionally impaired individuals
- •Pregnancies involving multiple fetuses
研究组 & 干预措施
Study Cohort
Healthy pregnant women of BMI between 20 and 40 kg/m2, height between 5 feet 2 inches and 5 feet 10 inches, who are having cesarean delivery under spinal or combined spinal epidural anesthesia.
干预措施: Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine (Drug)
结局指标
主要结局
Number of participants with spinal failure
时间窗: 90 minutes
A composite outcome that will be categorized as "yes" if there is either preoperative or intraoperative spinal failure. Preoperative failure will be defined as failure to achieve a T4 level to pinprick by the 15-minute timepoint. Intraoperative failure will be defined as pain (VAS \> 0) that requires anesthesia provider medication administration. Pain will be queried at time of skin incision, fetal delivery, uterine exteriorization, uterine interiorization or end of uterine closure, and end of skin closure. If VAS \> 0, the anesthesia provider will ask the patient if they would like analgesic medication. Discomfort at any other time during the cesarean delivery that is treated with neuraxial or intravenous analgesia will also count. Pain will be rated according to the scale: 0 = no pain, 10 = worst pain imaginable
次要结局
- Number of participants with conversion to another anesthetic technique(90 minutes)
- Number of participants with inadequate anesthesia(90 minutes)
- Patient satisfaction assessed by 5-point Likert scale, minimum value=1, maximum value=5, with higher values representing better patient satisfaction(2 Hours)
研究者
Brandon M Togioka
Principal Investigator
Oregon Health and Science University