Local Levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- 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 score of four or higher based on a 0-10 NRS. The peak pain score (maximum reported pain score) at one of the three pre-defined time points of 30, 60 and 90 minutes after the procedure will be used for this.
研究概览
简要总结
To evaluate the efficacy of local injection of levobupivacaine during esophageal ESD for direct post-procedural pain relief (within 90 minutes after ESD).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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
- •Allergy to LB or other amide-type local anaesthesia
- •Current regular use of opioids
- •Other aetiology causing pain similar to post-ESD pain
- •Pregnancy or breast feeding
- •Inability to assess pain due to severe psychiatric or neurological disease
- •Insufficient command of Dutch language
- •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
- •Brugada syndrome
- •Uncontrolled coagulopathy
- •Severe medical comorbidities precluding endoscopy
结局指标
主要结局
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 score of four or higher based on a 0-10 NRS. The peak pain score (maximum reported pain score) at one of the three pre-defined time points of 30, 60 and 90 minutes after the procedure will be used for this.
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 score of four or higher based on a 0-10 NRS. The peak pain score (maximum reported pain score) at one of the three pre-defined time points of 30, 60 and 90 minutes after the procedure will be used for this.
次要结局
- - Pain scores based on a 0-10 NRS within 90 minutes after the procedure, 6 hours after the procedure and thereafter daily up to day 14.
- - Cumulative pain throughout 14 days based on the area under the curve of a pain versus time plot.
- - Duration of pain, defined as the number of days until pain scores were reported to be 0 on all following days.
- - Daily and overall use of analgesics up to day 14 post-procedurally registered in a patient diary (electronic or on paper).
- - Incidence of adverse events related to LB administration (including allergic reactions to LB).
- - Incidence of serious adverse events related to LB administration (including allergic reactions to LB).
- - Length of hospital stay in days.
研究者
Laura Boer
Scientific
Sint Antonius Ziekenhuis Stichting