Efficacy of the Erector Spinae Plane Block for Abdominal Pain From Gastrointestinal Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Opioid Consumption
研究概览
简要总结
This study will target patients with gastrointestinal (GI) malignancy who present to any of 4 Penn Medicine emergency departments (EDs) with intractable abdominal pain. We will offer eligible patients an erector spinae plane block (ESPB), a regional anesthesia technique which is already offered to such patients in the ED at the University of Pennsylvania Healthy System (UPHS), for their intractable abdominal pain. We will compare the outcomes of this prospective cohort of patients to a matched historical control of patients with GI malignancy who were treated in the ED during the same time period as recruitment, but who were not recruited to partake in the study and who were managed with standard of care. Opioid consumption as measured by total milligram morphine equivalents (MMEs) over a 24-hour period and hospital length of stay (LOS) will be compared between cohorts. Additionally, for the ESPB cohort, pain level pre/post ESPB, and functionality and satisfaction with pain management at 24 hours will also be examined.
详细描述
This study will target patients with gastrointestinal (GI) malignancy who present to any of 4 Penn Medicine emergency departments (EDs) with intractable abdominal pain. We will offer eligible patients an erector spinae plane block (ESPB), a regional anesthesia technique which is already offered to such patients in the ED at the University of Pennsylvania Healthy System (UPHS), for their intractable abdominal pain. We will compare the outcomes of this prospective cohort of patients to a matched historical control of patients with GI malignancy who were treated in the ED during the same time period as recruitment, but who were not recruited to partake in the study and who were managed with standard of care. Opioid consumption as measured by total milligram morphine equivalents (MMEs) over a 24-hour period and hospital length of stay (LOS) will be compared between cohorts. Additionally, for the ESPB cohort, pain level pre/post ESPB, and functionality and satisfaction with pain management at 24 hours will also be examined.
Primary objective: To determine whether patients with GI malignancy receiving an ESPB for intractable abdominal pain consume less opioids (measured in MMEs) in a 24-hour period compared to standard of care analgesia.
Secondary objectives:
To determine whether patients who receive an ESPB have shorter hospital LOS compared to standard of care analgesia.
Within the cohort receiving the ESPB, to determine whether there was a change in pain level as measured by the numeric rating scale (NRS) pre/post block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age > 18 years old with GI malignancy presenting to a Penn Medicine ED with intractable abdominal pain.
- •Same-day or recent CT scan of the abdomen / pelvis which demonstrates that the patient's abdominal pain can be reasonably attributed to a malignant source.
排除标准
- •Allergy to ropivacaine or history of local anesthetic systemic toxicity.
- •Incarcerated
- •Patients being admitted for serial abdominal examinations to determine their surgical course.
- •Altered mental status or inability for patient to consent for the procedure
- •Hemodynamic instability
- •Previously enrolled in the study
研究组 & 干预措施
Treatment Arm -- Erector Spinae Plane Block
Patients with gastrointestinal malignancy and abdominal pain will receive the erector spinae plane block for their abdominal pain.
干预措施: Erector Spinae Plane Block (Procedure)
结局指标
主要结局
Opioid Consumption
时间窗: 24 hours
We will track the amount of opioids consumed within 24 hours by patients who received the erector spinae plane block
次要结局
- Length of Stay(1 week)
- Pain Levels(30 minutes)
- Revised American Pain Society Patient Outcome Questionnaire(24 hours)
研究者
Michael Shalaby
Assistant Professor of Emergency Medicine
University of Pennsylvania