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CTRI Number  CTRI/2024/07/070339 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 06/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Opioid Free Anaesthesia In Patients Undergoing Surgery For Pancreatic Cancer  
Scientific Title of Study   Opioid Free Anaesthesia In Pancreatico-Duodenectomy- Single Centre Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Taseen Mahvish 
Designation  Consultant Anaesthetist 
Affiliation  Basavatarakam Indo American Cancer Hospital And Research Institute 
Address  Department of Onco Anaesthesia And Critical Care, Block 1, fourth floor, Basavatarakam Indo American cancer hospital, Banjara Hills Road number 10, Hyderabad.
Department of Onco Anaesthesia And Critical Care, Block 1, fourth floor, Basavatarakam Indo American cancer hospital, Banjara Hills Road number 10 Hyderabad
Hyderabad
TELANGANA
500034
India 
Phone  9703372660  
Fax    
Email  taseen.mahvish@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Taseen Mahvish 
Designation  Consultant Anaesthetist 
Affiliation  Basavatarakam Indo American Cancer Hospital And Research Institute 
Address  Department of Onco Anaesthesia And Critical Care Block 1 fourth floor Basavatarakam Indo American cancer hospital Banjara Hills Road number 10 Hyderabad
Department of Onco Anaesthesia And Critical Care Block 1 fourth floor Basavatarakam Indo American cancer hospital Banjara Hills Road number 10 Hyderabad
Hyderabad
TELANGANA
500034
India 
Phone  9703372660  
Fax    
Email  taseen.mahvish@gmail.com  
 
Details of Contact Person
Public Query  
Name  Taseen Mahvish 
Designation  Consultant Anaesthetist 
Affiliation  Basavatarakam Indo American Cancer Hospital And Research Institute 
Address  Department of Onco Anaesthesia And Critical Care Block 1 fourth floor Basavatarakam Indo American cancer hospital Banjara Hills Road number 10 Hyderabad
Department of Onco Anaesthesia And Critical Care Block 1 fourth floor Basavatarakam Indo American cancer hospital Banjara Hills Road number 10 Hyderabad
Hyderabad
TELANGANA
500034
India 
Phone  9703372660  
Fax    
Email  taseen.mahvish@gmail.com  
 
Source of Monetary or Material Support  
Department of Onco Anesthesia and Critical Care Block 1 Fourth floor Basavatarakam Indo American Cancer Hospital And Research Institute Banjara Hills Road number 10 Hyderabad Telangana State India 500034 
 
Primary Sponsor  
Name  Basavatarakam Indo American Cancer hospital and Research Institute  
Address  Department of Onco Anaesthesia And Critical Care Block 1 Fourth floor Basavatarakam Indo American Cancer hospital and Research Institute Road number 10 
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 TASEEN MAHVISH  Basavatarakam Indo American cancer hospital and research institute  Department of Onco Anaesthesia And Critical Care Block 1 Fourth Floor Basavatarakam Indo American cancer hospital And Research institute Banjara Hills Road no 10 Hyderabad 500034
Hyderabad
TELANGANA 		 9703372660

taseen.mahvish@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Basavtarakam Indo American Cancer Hospital And Researah Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C250||Malignant neoplasm of head of pancreas,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. ASA status from 1to 3
2. Surgery whipples procedure
 
 
ExclusionCriteria 
Details  1. ASA 4
2. Local anaesthetic allergy
3. Infection at injection site
4. Coagulopathy
5. Critical coronary artery disease
6. Renal dysfunction
7. Hepatic dysfunction ( CTP SCORE of C)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To assess the no of patients requiring rescue opioid medications and the amount of opioid required in intravenous fentanyl equivalent   0 min, 30 mins , 60 mins, 90 mins , 120 mins , 4th hr , 6th hr , 8th hr, 12th hr, 24th hr , 28th hr, 32th hr, 36th hr, 40th hr, 44th hr, 48th hr, 52th hr, 56th hr, 60th hr, 64th hr, 68th hr, 72th hr  
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess changes in intraoperative hemodynamics i.e., before and after skin incision.
2. To assess the incidence post extubation post operative complication according to Clavein-Dindo classification
3. To assess the incidence of length of hospital stay and 30 day mortality

 		 before and after skin incision
30, 60, 90, 120 mins
3rd, 4th, 5th, 6th, 7th, 8th, 9th , 10th, 11th, 12th, 13th hr  
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   22/07/2024 
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="1"
Days="1" 
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 - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [divin7819@gmail.com].

  6. For how long will this data be available start date provided 22-10-2025 and end date provided 22-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Pancreatic cancer is an intractable malignancy and is ranked as the seventh leading cause of cancer related deaths worldwide as per the GLOBOCAN 2018  estimates , with a 5 yr survival rate of 9% despite advances in medical therapy. Pancreatico-duodenectomy also known as the whipples’procedure is the surgical procedure of choice for resectable pancreatic carcinomas.

opioids has been considered as the mainstay for pain management following pancreatic tumour resections, resulting in opioid related adverse effects like respiratory  depression , narcotic dependence , delayed gastric empyting and post-operative ileus, increased length of hospital stay cost burdern. 

They also have a profound potential for developing addiction , which is currently an epidemic in united states and overdose deaths from from synthetic opioid drugs have been skyrocketing over the last decade .

Therefore in solidarity of ERAS society recommendation , every effort to minimize opioid usage with implementation of opioid free anesthesia (OFA )strategies has to be considered.

Thus this study proposes the idealogy tht OFA strategy should be favoured in order to reduce the opioid relate adverse effects and improve perioperative pain management and recovery with multimodal analgesia .

AIiming To assess the feaseability of opioid free anesthesia for pancreatico-duodenal surgery

 
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