Health Condition 1: K861- Other chronic pancreatitis
Conditions
Interventions
Intervention1: 2% preservative-free lidocainesolution: The investigational product is 2% preservative-free lidocainesolution, administered via a nasopancreatic tube for immediate post-ERCP pain relief
Sponsors
DrPrashant Rahate
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 forparticipating 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 toreduced metabolite clearance 7 Heart failure or unstable cardiac disease unless clinically indicated and closelymonitored 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 ascimetidine 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 changein pain score (Numeric Rating Scale NRS) frombaseline to 15 minutes after each infusion(lidocaine or saline)Timepoint: 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 significantpain relief following nasopancreatic lidocaine infusion defined as areduction of greater than or equal to 2 points on the Numeric RatingScale or a final NRS score less than 2 Safety and Tolerability To evaluate the safety and tolerability of nasopancreatic lidocaineinfusion by documenting the incidence severity and type of adverseevents during and after the procedure Lidocaine Plasma Concentration and Clinical Correlation To measure plasma lidocaine levels following nasopancreatic infusionand explore their correlationTimepoint: Proportion of PainResponders Timepoint: 15 minutes post-infusion Safety and Tolerability Timepoint: During ERCP andup to 24 hours post-procedure or until discharge Lidocaine PlasmaConcentration and ClinicalCorrelation Timepoints: 15 minutes and30 minutes post-infusion | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
Seven Star Hospital
Outcome results
None listed