FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077073 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 25/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of pain relieving effectiveness of celiac plexus neurolysis against intravenous analgesic during percutaneous biliary surgeries in patients with upper abdominal malignancies 
Scientific Title of Study   Analgesic efficacy of celiac plexus neurolysis in patients undergoing percutaneous biliary intervention with upper abdominal malignancies 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vivek Patre 
Designation  Professor 
Affiliation  Pt. J.N.M. Medical college Raipur 
Address  B-20, Ravinagar, Shyam plaza, Pandri
Raipur
Raipur
CHHATTISGARH
492004
India 
Phone  9329399994  
Fax    
Email  drpatrevivek@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ghanshyam Verma 
Designation  Post graduation resident 
Affiliation  Pt. J.N.M. Medical college Raipur 
Address  Purani basti tilda, ward no. 19
Tilda-Neora, Post Neora
Raipur
CHHATTISGARH
493114
India 
Phone  7770848303  
Fax    
Email  ghanshyamverma450@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vivek Patre 
Designation  Professor 
Affiliation  Pt. J.N.M. Medical college Raipur 
Address  B-20, Ravinagar, shyam plaza, pandri
Raipur
Raipur
CHHATTISGARH
492004
India 
Phone  9329399994  
Fax    
Email  drpatrevivek@gmail.com  
 
Source of Monetary or Material Support  
Pt JNM Medical college Raipur Chhattisgarh Address- Moudhapara 492001, District Raipur, Chhattisgarh, INDIA 
 
Primary Sponsor  
Name  Pt. J.N.M. Medical College Raipur C.G. 
Address  Raipur, 492001, jail road, moudahapara 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ghanshyam Verma  PT J.N.M. MEDICAL COLLEGE RAIPUR  Department of radio-diagnosis, Ground floor Pt JNM medical college affiliated Dr. BRAMH hospital Raipur, moudhapara 492001
Raipur
CHHATTISGARH 
7770848303

ghanshyamverma450@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMITEE PT JNM MEDICAL COLLEGE RAIPUR (C.G.)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C221||Intrahepatic bile duct carcinoma, (2) ICD-10 Condition: C170||Malignant neoplasm of duodenum, (3) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (4) ICD-10 Condition: C24||Malignant neoplasm of other and unspecified parts of biliary tract, (5) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, (6) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Celiac Plexus Neurolysis  Percutaneous CT guided retrocrural space injection of 10% liquid phenol in celiac ganglion leading to abolishment of pain sensation arising from celiac plexus during percutaneous biliary intervention 
Comparator Agent  Intravenous Analgesic  Analgesic effect of intravenous injection of analgesic (narcotic class) while performing percutaneous biliary intervention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1) Adults with upper abdominal malignancy
2)Should have pain (score in NRS equals or more than 7 out of 10)
3) Should have biliary dilatation and clinical jaundice
 
 
ExclusionCriteria 
Details  Ascites, Hepatic encephalopathy, Patient denial, Active biliary infection 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain intensity in terms of NRS score  Immediate and 1 day post op 
 
Secondary Outcome  
Outcome  TimePoints 
Complication rate  Day 0 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/07/2025 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  will be published at journal

  6. For how long will this data be available start date provided 26-06-2024 and end date provided 26-04-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

     Malignant biliary obstruction is an enfeebling condition that can causes pain, jaundice, pruritus, anorexia, metabolic encephalopathy and later can cause mortality. For its definitive management biliary decompression is performed via endoscopic, percutaneous, and surgical approaches. Minimally invasive (Percutaneous) techniques are now choice of care, preferable to conventional surgical bypass because of lower intraprocedural morbidity and lower overall hospital stay.

Percutaneous biliary drains are often painful due to measures during PTBD provoke intense pain sensations of very short duration such as mechanical stretching of biliary tree, peritoneal transgressions or balloon dilatation procedures and caustic nature of bile which may inflame the skin near the insertion site, Therefore, another measures to be taken care about is the optimal pain management of the patients undergoing percutaneous biliary intervention.

 

Another point of concern is the development of tolerance to opioid analgesics which is a major barrier to clinical opioid therapy. Opioid tolerance is a pharmacological phenomenon caused by repeated opioid exposure leads to receptor resistance that causes decreased analgesic effects. hence the effective means to ease the intractable visceral pain associated with abdominal malignancy is to interrupt the nociceptive impulses at the level of the celiac plexus or splanchnic nerves.

 

So our aim of the study is to assess the Analgesic efficacy of celiac plexus neurolysis in patients undergoing percutaneous biliary intervention with upper abdominal malignancies.

Firstly the patient with upper GI malignancy with pain score equal to or more than 7 with biliary dilatation will be taken for study with no exclusion criteria should be met. After pre-operative assessment, proper written consent the patient will be divided into 2 groups, 1st group will receive Celiac plexus neurolysis for the management of pain followed by percutaneous biliary intervention while the 2nd group will be directed to percutaneous biliary intervention with support of intravenous analgesia inter-operatively.

 

Our objective is to asses the peri-operative and post-operative (1 day) pain with the help of NRS (numerical response scale) in both groups.

Followed by comparison of mean NRS score in both groups using required software (SPSS) and calculate the test of significance.

 
Close