Local Levobupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 3
- 主要终点
- Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial
研究概览
简要总结
Endoscopic submucosal dissection (ESD) is commonly performed for (pre)cancerous lesions in the esophagus. Following ESD, post-procedural chest pain is seen in many patients. Studies have shown that local bupivacaine (BP) into the residual submucosal layer of the resection wound after gastric ESD could reduce post-procedural pain rates effectively. Levobupivacaine (LB) is equipotent to BP regarding analgesic effects, but has a better safety profile. No studies have been performed to evaluate the efficacy of LB after esophageal ESD to reduce pain. Therefore, we want to evaluate the effect on post-procedural pain of local application of LB during esophageal ESD.
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
- Double (Participant, Outcomes Assessor)
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 at time of consent
- •Visible lesion in the esophagus, minimum diameter of the lesion ≥20 mm
- •Scheduled for esophageal ESD
- •Informed consent
排除标准
- •Presence of multiple lesions requiring two or more separate endoscopic resections
- •History of esophageal surgery other than fundoplications
- •History of esophageal ablation therapy
- •History of radiotherapy of the esophagus
- •Esophageal varices
- •Prior endoscopic resection in the same area
- •Uncontrolled coagulopathy
- •Severe medical comorbidities precluding endoscopy
- •Allergy to LB or other amide-type local anaesthesia
- •Current regular use of opioids
- •Other aetiology causing pain similar to post-ESD pain
- •Inability to assess pain due to severe psychiatric or neurological disease
- •Insufficient command of Dutch language
- •Brugada syndrome
- •Incapacitated patients
研究组 & 干预措施
Levobupivacaine
levobupivacaine submucosally injected during esopahgeal esd
干预措施: Local levobupivacaine (Drug)
结局指标
主要结局
Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial
时间窗: 90min
The proportion of patients with major pain within 90 minutes after the procedure comparing the LB and non-LB group. Major pain is defined as a pain score of 4 or higher on a 0-10 Numeric Rating Scale (NRS). The highest pain score reported at any of the three pre-defined time points (30, 60, or 90 minutes after the procedure) will be used to determine if a patient experienced major pain
次要结局
- Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial(14 days)
研究者
Laura Boer
Prof. Dr. BLAM Weusten
St. Antonius Hospital