跳至主要内容
临床试验/NCT03405311
NCT03405311终止不适用

3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient: A Randomized Control Trial

The University of Texas Medical Branch, Galveston1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
40
试验地点
1
主要终点
Number of Needle Insertion Attempts Calculated Across All Participants

研究概览

简要总结

This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device).

详细描述

Worldwide obesity has become an epidemic. The obstetrical population is no exception. This made more challenging for anesthesiologists on labor and delivery units to administer epidural analgesia. According to the World Health Organization, more than 30% of U.S. adults are obese with a body mass index (BMI; in kg/m2) ≥ 30. Recent data has shown that increased BMI has been associated with increased neuraxial analgesic failure and difficulty with prolonged epidural placement time.

The 'Blind approach' is the current standard of care in administering neuraxial anesthesia. The physician palpates the patient's spinal bony landmarks; the needle is placed in relation to identified landmarks and inserted until loss of resistance is felt. In the obese population, the success rates are as low as 68%. Recently the FDA has approved a handheld device "The Accuro" as an adjunct for neuraxial analgesia (Rivanna Medical, LLC). It consists of a three-dimensional ultrasound device. By utilizing sound waves it constructs three-dimensional images of the spinal column, allowing the physician to better see the spine in order to perform spinal/epidural anesthesia.

Hypothesize that this device will enable clinicians to assess epidural spaces for epidural needle placement compared with the traditional Blind approach in the morbidly obese parturient.

This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device). Also, will determine if ultrasound based landmarks would reduce the needle tract and thereby reduced the amount of post-procedure pain at the insertion site in the peripartum period by using the algometer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status class I, II, or III.
  • Term pregnancy.
  • Requesting epidural analgesia for anticipated vaginal delivery.
  • BMI>or = 40.

排除标准

  • Contraindication for epidural analgesia
  • Inability to adequately understand the consent form.
  • Incarcerated patients.
  • Patients with known spinal deformities.
  • Allergies to ultrasound gel.
  • Allergies to local anesthetics

研究组 & 干预措施

Palpation

Active Comparator

The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.

干预措施: Palpation (Other)

Rivanna Accuro 3D Ultrasound Device

Experimental

The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.

干预措施: Rivanna Accuro 3D Ultrasound Device (Device)

结局指标

主要结局

Number of Needle Insertion Attempts Calculated Across All Participants

时间窗: Beginning of needle insertion till catheter placement-15 minutes

An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt.

Number of Participants With Successful Epidural Catheter Placements

时间窗: Within first 90 minutes following catheter placement

Number of Participants With Successful Epidural Catheter Placements.

Number of Needle Insertion Redirections Calculated Across All Participants

时间窗: Beginning of needle insertion till catheter placement-15 minutes

An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt.

次要结局

  • Procedural Difficulty Rated by the Performing Anesthesiologist on a 10-point Likert Scale(Beginning of needle insertion till catheter placement-15 minutes)
  • Needle Depth(Beginning of needle insertion till catheter placement-15 minutes)
  • Pressure Pain Thresholds(Before epidural placement)
  • Number of Complications Recorded Calculated Across All Participants(Within 30 days of admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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