Erector Spinae Plane Block for Patients With Intractable Abdominal Pain in the Emergency Department: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Pain Score
研究概览
简要总结
Currently, the standard treatment of nonsurgical abdominal pain in the Emergency Department (ED) includes narcotic pain medication. This can be addictive and contributes to the current opioid epidemic. Recent studies have shown that the Erector Spinae Plane Block (ESPB) is an alternative approach to achieving abdominal analgesia without the use of any systemic pain medications. It is a regional nerve block that can be used by emergency medicine physicians by injecting anesthetic into the erector spinae plane under ultrasound guidance, which effectively anesthetizes the abdomen. This procedure is within the scope of practice of Emergency Medicine residents, fellows, and attendings who have received training in Point-of-Care Ultrasound (POCUS) and who have also received specialized training on how to perform the ESPB under ultrasound guidance. Adult patients will be screened for intractable abdominal pain (persistent pain despite systemic pain medications) and eligibility to receive the nerve block (for example, patients cannot be pregnant, must be able to verbalize pain and satisfaction scores, and must have no contraindication to receiving the nerve block). In this study, the investigators will perform a small pilot study to determine how effective the ESPB is compared to systemic pain medications, and how easy or difficult it is to perform the ESPB in the Emergency Department as a means of controlling abdominal pain.
详细描述
This study takes an effectiveness-implementation Hybrid Type 2 trial design with a dual purpose: (i) to examine the effectiveness of the Erector Spinae Plane Block (ESPB) compared to standard systemic pain medication in patients with intractable, nonsurgical abdominal pain in the Emergency Department (ED); and (ii) to qualitatively analyze the feasibility of implementing the ESPB in the Emergency Department as a means of controlling abdominal pain. The investigators hypothesize that patients with intractable, nonsurgical abdominal pain who receive the ESPB will have non-inferior pain scores compared to patients who receive systemic pain medications. The investigators further hypothesize that patients who receive the ESPB will require fewer Morphine Milligram Equivalents (MME) to achieve abdominal pain control than patients who do not receive the ESPB. The investigators aim to identify potential challenges that could affect the feasibility of implementing the ESPB in the Emergency Department setting, such as time constraints, lack of provider willingness to perform the block, lack of patient willingness to receive the block, and difficulty finding the appropriate supplies.
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
- 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
- •Over 18 years of age
- •Abdominal pain that is intractable, defined as pain persisting despite administration of more than one dose of narcotic medication
- •Nonsurgical abdominal pain, determined by either a benign abdominal exam not warranting a computed tomography (CT) scan, or a CT scan showing no identifiable surgical process
- •Patient may present from the Emergency Department (ED) or may be an admitted inpatient
排除标准
- •Under 18 years of age
- •Pregnant, confirmed by a positive pregnancy test sent on all female patients of childbearing age presenting with abdominal pain
- •Psychiatric patients
- •Unable to verbalize a pain score, or impaired decision-making capacity (e.g., obtunded, intoxicated, lethargic, critically ill, intubated, or cognitively impaired)
- •Any contraindication to nerve blocks, such as infection overlying the injection site, a bleeding disorder, or an allergy to anesthetic
- •Surgical abdomen requiring serial abdominal exams
研究组 & 干预措施
Erector Spinae Plane Block (ESPB)
Patients receive the erector spinae plane block (ESPB) via ultrasound-guided injection of bupivacaine, with systemic analgesics provided as needed if pain persists.
干预措施: Bupivacaine (erector spinae plane block) (Drug)
Standard Systemic Pain Medication
Patients receive standard-of-care systemic pain medication (non-opioid analgesics or opioids such as Norco/hydrocodone-acetaminophen).
结局指标
主要结局
Change in Pain Score
时间窗: Baseline (time of consent), 30 minutes post-intervention, and 3 hours post-intervention
Change from baseline in patient-reported pain intensity, measured on a standardized Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.
次要结局
- Patient Satisfaction Score(Prior to Emergency Department discharge, up to 24 hours)
- Total Emergency Department Length of Stay(From Emergency Department arrival to disposition, up to 24 hours)
- Time Required to Perform the Erector Spinae Plane Block (ESPB)(At the time of the procedure, up to 3 hours)
- Number of Participants With Pneumothorax(Through Emergency Department stay, up to 24 hours)
- Number of Participants With Local Anesthetic Systemic Toxicity (LAST)(Through Emergency Department stay, up to 24 hours)
- Number of Participants With Opioid-Related Adverse Events(Through Emergency Department stay, up to 24 hours)
研究者
Megan Guy
Assistant Clinical Professor, Associate Ultrasound Fellowship Director Department of Emergency Medicine
University of California, Irvine