Changes in Sensory Block Level During a Programmed Intermittent Epidural Bolus Regimen for Labor Analgesia: an Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Upper sensory block level over time
研究概览
简要总结
Epidural analgesia is widely used for managing pain during labor. The programmed intermittent epidural bolus (PIEB) technique has been shown to produce less consumption of local anesthetics, better sensory block, less motor block, and increased maternal satisfaction than other epidural analgesia techniques. Despite all benefits from PIEB, such practice has been associated with high sensory block levels. Therefore, assessment of the sensory block level is an essential component of clinical safety. The lack of a standardized technique and timing to assess the sensory block level can lead to inappropriate management. The purpose of this study is to investigate the changes in block level over time, during cycles of a PIEB regimen. The investigators hypothesize that these levels will be highest soon after the PIEB bolus and lowest preceding the subsequent PIEB bolus. The investigators also want to investigate a possible correlation between these changes in sensory block levels and motor block, pain scores, and rescue bolus of local anesthetics.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women admitted to the Labor and Delivery unit at Mount Sinai Hospital that request and have no contraindications to receive epidural analgesia
- •18 years old or more
- •capable of understanding and signing the written informed consent
- •have no language barrier to respond to the level of sensory block assessment
- •and have no conditions that could compromise the body sensitivity to cold.
排除标准
- •unintentional dural puncture during labour epidural placement
- •do not achieve adequate pain control 20 minutes after the loading dose (numeric rating scale (NRS)>1 on a 0-10 NRS),
- •deliver before 160 minutes following the loading dose
- •require rescue boluses in the first 80 minutes after initiation of PIEB (that is, before the 2nd PIEB bolus)
- •withdraw their consent.
结局指标
主要结局
Change in Upper sensory block level over time
时间窗: 20 to 160 minutes post-loading dose
The upper sensory block level to ice is defined as the dermatome at which there is an altered cold perception without complete sensitivity loss. This will be measured at 20, 60, 80, 90, 100, 110, 120, 130, 140, 150, and 160 minutes post-loading dose of epidural medication.
Change in Lower sensory block level over time
时间窗: 20 to 160 minutes post-loading dose
The lower sensory block level to ice, defined as the dermatome at which there is a complete loss of cold perception. This will be measured at 20, 60, 80, 90, 100, 110, 120, 130, 140, 150, and 160 minutes post-loading dose of epidural medication.
次要结局
- Motor block score using Bromage score(20 to 160 minutes post-loading dose)
- Pain score(20 to 160 minutes post-loading dose)
- Additional analgesia administered(160 minutes)