Health Condition 1: K861- Other chronic pancreatitis
Conditions
Interventions
Intervention1: Lidocaine (nasopancreatic infusion): 5-10 mL of 2% Lidocaine solution will be administered via a nasopancreatic catheter into the pancreatic duct immediately following the completion of
Sponsors
DrAjay Kumar
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)Timepoint: From baseline to 15 minutes after each infusion (lidocaine or saline) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Safety and Tolerability To evaluate the safety and tolerability of nasopancreatic lidocaine infusion by documenting the incidence severity and type of adverse events during and after the procedure Lidocaine Plasma Concentration and Clinical Correlation To measure plasma lidocaine levels following nasopancreatic infusion and explore their correlation with the degree of pain relief experienced by the patientTimepoint: Proportion of Pain Responders Timepoint: 15 minutes post-infusion Safety and Tolerability Timepoint: During ERCP and up to 24 hours post-procedure or until discharge Lidocaine Plasma Concentration and Clinical Correlation Timepoints: 15 minutes and 30 minutes post-infusion | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
BLK -Max Super Speciality Hospital
Outcome results
None listed