Randomized, Double-Blind, Crossover Clinical Study of Nasopancreatic Lidocaine versus Saline Infusion for Immediate Post-ERCP Pain Relief in Patients with Chronic Pancreatitis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The primary endpoint will evaluate the change in pain score (Numeric Rating Scale NRS) from baseline to 15 minutes after each infusion (lidocaine or saline)
研究概览
简要总结
This is a randomized, double blind, two treatment, two period crossover clinical study designed to evaluate the effectiveness of nasopancreatic lidocaine infusion in reducing immediate post procedure pain in patients with chronic pancreatitis undergoing ERCP. Each subject will receive both treatments lidocaine and normal saline in two separate ERCP sessions. Pain will be assessed using the Numeric Rating Scale at baseline and fifteen minutes after the infusion. The study also aims to evaluate the safety and tolerability of lidocaine infusion by monitoring adverse events, and to measure plasma lidocaine concentrations to explore their correlation with pain relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Eligibility of the subjects will be evaluated on Day 1 and individual subject must meet all the following criteria to be considered eligible for participating in the study 1 Both male and female adults aged more than 18 years 2 Established diagnosis of painful chronic pancreatitis confirmed by prior clinical evaluation and imaging with or without evidence of pancreatic insufficiency 3 Undergoing ERCP with pancreatic duct cannulation for diagnostic or therapeutic purposes as per standard of care 4 Report a post-ERCP pain score greater than or equal to 2 on a 0–10 Numeric Rating Scale (NRS) upon recovery from anesthesia.
排除标准
- •Individuals who meet any of the following criteria will be considered ineligible for participating in the study 1 Known allergy or hypersensitivity to lidocaine or other amide-type local anesthetics 2 History of severe adverse reactions to lidocaine including anaphylaxis 3 History of methemoglobinemia or significant hemoglobinopathy 4 Presence of severe cardiac conduction abnormalities such as Wolff-Parkinson-White syndrome Stokes-Adams syndrome Severe heart block sinoatrial atrioventricular or intraventricular 5 Significant hepatic impairment which may reduce lidocaine metabolism 6 Severe renal insufficiency particularly in the context of multiple lidocaine doses due to reduced metabolite clearance 7 Heart failure or unstable cardiac disease unless clinically indicated and closely monitored 8 Pregnant or breastfeeding women 9 Body weight less than 40 kg 10 Inability to communicate or understand the study protocol requirements 11 Concurrent use of medications that may interfere with lidocaine metabolism such as cimetidine beta-blockers 12 Recent myocardial infarction within the past 6 months 13 Use of systemic corticosteroids or chronic opioid therapy.
结局指标
主要结局
The primary endpoint will evaluate the change in pain score (Numeric Rating Scale NRS) from baseline to 15 minutes after each infusion (lidocaine or saline)
时间窗: From baseline to 15 minutes after each infusion (lidocaine or saline)
次要结局
- Proportion of Pain Responders(To assess the proportion of patients who achieve clinically significant pain relief following nasopancreatic lidocaine infusion defined as a reduction of greater than or equal to 2 points on the Numeric Rating Scale or a final NRS score less than 2)
研究者
DrAjay Kumar
BLK -Max Super Speciality Hospital