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CTRI Number  CTRI/2024/01/061167 [Registered on: 05/01/2024] Trial Registered Prospectively
Last Modified On: 29/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Other (Specify) [Pain Management]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of nerve block with opiod in relieving pain of patients with acute pancreatitis  
Scientific Title of Study   Comparision of efficacy of erector spinae plane block versus conventional pharmacological therapy in successfully alleviating abdominal pain of patients with pancreatitis in an emergency department: A Randomized Control Trial 
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 Satyendra Meena 
Designation  Junior Resident 
Affiliation  AIIMS, New Delhi 
Address  AIIMS Emergency Office, Department of Emergency Medicine, AIIMS, New Delhi-110029
Hostel 18, Room 228, Kashyap Hostel, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India 
Phone  9643131943  
Fax    
Email  satensmeena@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjeev Bhoi 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  AIIMS Emergency Office, Department of Emergency Medicine, AIIMS, New Delhi-110029

New Delhi
DELHI
110029
India 
Phone  8527050391  
Fax    
Email  sanjeevbhoi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Satyendra Meena 
Designation  Junior Resident 
Affiliation  AIIMS, New Delhi 
Address  AIIMS Emergency Office, Department of Emergency Medicine, AIIMS, New Delhi-110029
Hostel 18, Room 228, Kashyap Hostel, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India 
Phone  9643131943  
Fax    
Email  satensmeena@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  Department of Emergency Medicine 
Address  AIIMS, New Delhi-110029 
Type of Sponsor  Research institution and hospital 
 
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 Satyendra Meena  All India Institute of Medical Sciences, New Delhi  EM-1, Department of Emergency Medicine
New Delhi
DELHI 
9643131943

satensmeena@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, (2) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bilateral Erector Spinae Plane Block  Ultrasound guidance Bilateral erector spinae plane block will be done on arrival by inserting a nerve block needle with 0.5% Bupivacaine (calculated amount by bodyweight) and 4 mg of Dexamethasone, following that a patient-controlled analgesia pump or PCA pump will be provided which will contain injection Fentanyl as rescue therapy. Patient will be asked to press the PCA pump button whenever he feels pain, a predetermined amount of fentanyl will be delivered. The demand dose for fentanyl will be 0.3 μg/kg with a lockout interval of 15 minutes and a 1-hour limit of 1.2 μg/kg. The total number of demands of rescue analgesia through the PCA will be calculated at 12 hours and 24 hours. 
Comparator Agent  Conventional Pharmacological Therapy  Patient will be given injection tramadol 50 mg intravenously bolus thrice a day, along with that a patient-controlled analgesia pump or PCA pump will be provided which will contain injection Fentanyl as rescue therapy. Patient will be asked to press the PCA pump button whenever he feels pain, a predetermined amount of fentanyl will be delivered. The demand dose for fentanyl will be 0.3 μg/kg with a lockout interval of 15 minutes and a 1-hour limit of 1.2 μg/kg. The total number of demands of rescue analgesia through the PCA will be calculated at 12 hours and 24 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Adults patients (≥ 18 years of age) who are
already diagnosed as acute or recurrent
acute pancreatitis, presenting to the
emergency department of AIIMS New
Delhi within 7 days of onset of abdominal
pain with DVPRS ≥ 7.
2. Patients willing to give consent. 
 
ExclusionCriteria 
Details  1. Patients with hemodynamic instability
2. Patients having one or more organ
dysfunction
3. Patients allergic to drugs
4. Local site infection
5. Spine deformity (both acquired or
congenital)
6. Pregnancy
7. Immunosuppressive state
8. Patients with chronic kidney disease,
chronic liver disease, congestive heart
failure 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of successful pain relief (more than 50% reduction in pain score by Defense and Veterans Pain Scale(DVPRS) from presentation or DVPRS less than 4 or total
amount of rescue analgesia needed) after six hours of intervention in both ESPB arm
and conventional pharmacological therapy (CPT) arm. 
Primary outcome will be assessed and analysed after six hours of intervention in both ESPB arm
and conventional pharmacological therapy (CPT) arm. 
 
Secondary Outcome  
Outcome  TimePoints 
Drugs or procedure related adverse events in both arm  Upto 6 hours after intervention or 24 hours if
patient remains in the emergency department 
Pain score assessment at different time interval (at 1 hour, 6 hours, then every 6
hours up to 24 hours) 
Upto 6 hours after intervention or 24 hours if
patient remains in the emergency department 
Pain free interval in both arm: It will be defined as either DVPRS less than 4 or no need of
rescue analgesia. 
Upto 6 hours after intervention or 24 hours if
patient remains in the emergency department 
Timing of rescue therapy in both arm and total cumulative dose of fentanyl as rescue
therapy after 12 and 24 hours 
Upto 6 hours after intervention or 24 hours if
patient remains in the emergency department 
Patient feedback based on Likert scaling regarding preference of therapy he or she
would opt for in next visit 
Upto 6 hours after intervention or 24 hours if
patient remains in the emergency department 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   10/01/2024 
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="1"
Months="0"
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 - NO
Brief Summary  
It is a prospective, open label, randomized control trial of parallel-groups to compare the efficacy of erector spinae plane block versus conventional pharmacological therapy in successfully alleviating abdominal pain of patients with pancreatitis in an Emergency Department. Patients of pancreatitis with Abdominal pain will be examined and history will be taken, patients meeting inclusion criteria will be included in the study after taking consent for the study. Patients meeting any one of the exclusion criteria will be excluded from the study. After that, randomization to different study arm patient will be allcocated, randomization will be done by a pre-formed computer generated randomization table and allocation concealement will be done by SNOSE technique. Our primary objective is to assess the efficacy of successful pain relief (more than 50% reduction in pain score by DVPRS from presentation or DVPRS less than 4 in both arm at one hour in both ESPB arm and conventional pharmacological therapy (CPT) arm. Secondary objectives are to assess pain score assessment at different time interval up to 6 hours or up to 24 hours if patient remains in ED, pain free interval in both arm, timing of rescue therapy, drugs or procedure related adverse events in both arm, reasons for failure of therapy in both arm, efficacy of image acquisition and optimization and interpretation by different performers on Likert scale, patient feedback based on Likert scaling regarding preference of therapy he or she would opt for in next visit.
 
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