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CTRI Number  CTRI/2025/09/094488 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 07/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Randomized Crossover Trial: Nasopancreatic Lidocaine vs. Saline for Post-ERCP Pain in Chronic Pancreatitis 
Scientific Title of Study   Randomized, Double-Blind, Crossover Clinical Study of Nasopancreatic Lidocaine versus Saline Infusion for Immediate Post-ERCP Pain Relief in Patients with Chronic Pancreatitis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NP-LIDO/CT/2025/01, Version 1.0 Dated 07-Jul-2025   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAjay Kumar  
Designation  Chairman and HOD -Gastroenterology and Hepatology  
Affiliation  BLK -Max Super Speciality Hospital  
Address  Room No 161 OPD 7 1st Floor BLK Max Super Speciality Hospital Pusa Road New Delhi 110005

New Delhi
DELHI
110005
India 
Phone  9811040985  
Fax    
Email  ajaykge@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAjay Kumar  
Designation  Chairman and HOD -Gastroenterology and Hepatology  
Affiliation  BLK -Max Super Speciality Hospital  
Address  Room No 161 OPD 7 1st Floor BLK Max Super Speciality Hospital Pusa Road New Delhi 110005

New Delhi
DELHI
110005
India 
Phone  9811040985  
Fax    
Email  ajaykge@hotmail.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Devesh Kumar  
Designation  Founder and Managing Director 
Affiliation  IR Innovate Research Pvt. Ltd 
Address  C120 SECTOR 2 UTTAR PRADESH 201301 India Gautam Buddha Nagar UTTAR PRADESH 201301 India

Gautam Buddha Nagar
UTTAR PRADESH
110034
India 
Phone  7827758840  
Fax    
Email  devesh.kumar@innovate-research.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor
Modification(s)  
Name  DrAjay Kumar 
Address  BLK -Max Super Specialist Hospital, Pusa Road New Delhi- 110005 Pan Max Gastroenterology & Hepatology Department of Gastroenterology and Hepatology Dr. B. L. Kapur Memorial Hospital Pusa Road, New Delhi-11000S. 
Type of Sponsor  Other [Investigator Initiated study ] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Kumar  Dr B L Kapur Memorial Hospital   Room No 161 OPD 7 1st Floor BLK Max Super Speciality Hospital Pusa Road NewDelhi 110005 New Delhi DELHI 110005 India
New Delhi
DELHI 		 91 9811040985

ajaykge@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. B. L. Kapur Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K861||Other chronic pancreatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% normal saline  The comparator is 0.9% normal saline, used as a placebo control.  
Intervention  2% preservative-free lidocaine solution,   The investigational product is 2% preservative-free lidocaine solution, administered via a nasopancreatic tube for immediate post-ERCP pain relief. The study duration for each subject is 01 day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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)  From baseline to 15 minutes after each infusion (lidocaine or saline) 
 
Secondary Outcome  
Outcome  TimePoints 
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 patient 		 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 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 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. 
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