Pre-insertion Ultrasound Guidance for Labor Epidural Placement in the Lateral Position: A Randomized Controlled Trial of Image Reproducibility During Labor and Impact on Resident Learning Curve
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound.
研究概览
简要总结
The aim of this study is to evaluate the impact of lumbar spine ultrasound on the success rate and efficiency of labor epidural placement in the lateral position. The investigators hypothesize that ultrasound imaging of the lumbar spine of women in early labor will yield similar ultrasound results when done immediately prior to epidural placement. The investigators also hypothesize that the use of ultrasound with landmarks marked and depth to the epidural space estimated will facilitate epidural placement in terms of both efficiency (time required for placement) and efficacy of pain relief.
详细描述
Several studies have demonstrated a significant benefit in pre-procedural ultrasound for epidural placement by anesthesia residents, particularly when performed in the obese population. To the investigators knowledge, however, no studies have evaluated this teaching modality for the lumber epidural technique in the lateral position. Formalizing the educational process for this less frequently performed, highly technical and critical skill may have a profound impact on trainee learning curves, and may enhance the overall success and efficiency of epidural placement, quality of analgesia provided, and safety of the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •pregnant women
- •18 years or older
- •in early labor (cervix dilated < 5 cm
- •pain visual analog score (VAS) < 3, or both) requesting consultation by the anesthesia team for anticipated epidural pain relief.
排除标准
- •absolute contraindications of neuraxial anesthesia including patient refusal
- •uncorrected coagulopathy
- •infection at the skin site of epidural placement
- •increased intracranial pressure, or untreated hemodynamic instability.
- •In addition, patients with a history of scoliosis or spine surgery
- •body mass index (BMI) >40 kg/m2
- •allergy to local anesthetic, or allergy to opioids will be excluded.
- •Anesthesiologists
- •Inclusion criteria:
- •Anesthesia residents or fellows who are performing the epidural technique in pregnant subjects who agree to be part of the study.
- •Anesthesia residents or fellows with prior experience in the lumbar epidural technique, defined as having placed 20 or greater lumbar epidurals during their residency and prior to enrollment.
- •Exclusion criteria:
- •individuals who do not want to participate in the study.
结局指标
主要结局
Depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound.
时间窗: From enrollment to time of epidural placement, approximately 5 hours
Measured depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, midline, at level L3-4.
Time required for epidural placement
时间窗: From enrollment to time of epidural placement, approximately 5 hours
Time required for placement (T0 = insertion of needle for subcutaneous lidocaine infusion prior to epidural needle placement). Tfinal = time at complete removal of Weiss epidural needle after catheter is threaded into the epidural space.
Need for assistance from additional anesthesiologist
时间窗: From enrollment to time of epidural placement, approximately 5 hours
Need for assistance from additional anesthesiologist
Number of attempts at epidural placement
时间窗: From enrollment to time of epidural placement, approximately 5 hours
defined as number of times the Weiss epidural needle enters the skin
Incidence of paresthesias
时间窗: From enrollment to time of epidural placement, approximately 5 hours
Paresthesia defined as pain with needle or catheter insertion
Labor pain at time of 30 minutes after placement is complete.
时间窗: From enrollment to time of epidural placement, approximately 5 hours, plus 30 minutes.
Labor pain rated on a visual analog scale (VAS)
Rate of epidural replacement for inadequate analgesia
时间窗: From enrollment to time of epidural placement, approximately 5 hours
Inadequate analgesia determined as VAS \>3 despite catheter adjustment and/or epidural dose adjustment.
Rate of inadvertent dural puncture at the time of placement.
时间窗: From enrollment to time of epidural placement, approximately 5 hours
Defined as cerebrospinal fluid aspiration through needle or catheter.
Midline measurement from baseline ultrasound compared to pre-placement ultrasound.
时间窗: From enrollment to time of epidural placement, approximately 5 hours
Measured midline (anatomical marking) from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, midline.
L3-L4 lumbar spine level measured from baseline ultrasound compared to pre-placement ultrasound.
时间窗: From enrollment to time of epidural placement, approximately 5 hours
Measured L3-L4 lumbar spine level from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, paramedic.
次要结局
未报告次要终点
研究者
Michaela Kristina Farber, MD
Principal Investigator
Brigham and Women's Hospital