Intrapartum Epidural Catheter Displacement: Comparison of Three Dressing Methods in Morbidly Obese Parturients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Epidural Catheter Migration
研究概览
简要总结
Failure of labor epidural is a well-recognized situation in obstetric anesthesia practice. Incidence of epidural failure was shown to be 12% in a retrospective analysis of 19,259 deliveries. Epidural migration has been documented in both the obstetric and non-obstetric settings. It has been argued that prevention of epidural displacement is a potential remedy to at least part of the incomplete or failed epidurals in obstetrics.
Purpose: The investigators propose this study to prospectively evaluate the efficacy of the three types of epidural catheter dressings that are currently in use in clinical practice, in terms of catheter migration, taking into consideration the influence of body mass index on this variable.
详细描述
Primary aim: The investigators will evaluate the efficacy of three different epidural catheter dressing systems in laboring patients.
Secondary aims: To compare the effect of different degrees of obesity measured by BMI, on epidural catheter migration and quality and failure of epidural labor analgesia. To evaluate the effect of time an indwelling catheter remains in place, level of insertion and patient's height on epidural catheter migration.
Hypothesis
The use of dressing with transparent TegadermTM plus catheter support pad dressing is superior to the dressing with TegadermTM plus Steri-StripTM bands, and to a dressing with TegadermTM only, for epidural catheter fixation in laboring obese and morbidly obese patients, in terms of catheter migration. epidural quality and failure and epidural catheter replacement in the labor analgesia setting.
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
- None
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
- •Patients admitted to the Labor and delivery Unit at Augusta University Medical Center who request epidural analgesia.
- •BMI >30 kg/m
- •Age older than 18 years old.
排除标准
- •Allergy to adhesive tape or to the components of the dressings used in the study.
- •Preexisting sensory neurologic deficits affecting lower extremities.
- •Patients taken to the operating room for cesarean section during the study period.
- •Chronic pain conditions.
- •Patients with intrathecal catheters.
结局指标
主要结局
Epidural Catheter Migration
时间窗: 24 hours. The time from insertion to removal of catheter
Percentage of participants for whom catheter migration was observed
次要结局
- Rate of Epidural Catheter Replacement(24 hours. The time from insertion to removal of catheter due to failure)
研究者
Efrain Riveros Perez, MD
Assistant Professor Department of Anesthesiology and Perioperative Medicine
Augusta University