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CTRI Number  CTRI/2023/06/053483 [Registered on: 02/06/2023] Trial Registered Prospectively
Last Modified On: 02/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Assesment of postoperative pain using tool called perfusion index 
Scientific Title of Study   Perfusion index as a tool for acute postoperative pain assessment; In correlation with Visual Analogue Score for pain assessment  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr AMITHAB S R 
Designation  Second year Anesthesia Resident 
Affiliation  New Civil Hospital, Goverment medical college, Surat 
Address  No18, OPD block, Anesthesia department, New Civil Hospital, Majura Gate, Surat, Gujarat

Surat
GUJARAT
395001
India 
Phone  7034258047  
Fax    
Email  amithab.pkv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr HARSHA PATEL 
Designation  Additional Professor 
Affiliation  New Civil Hospital, Goverment medical college, Surat 
Address  No18, OPD block, Anesthesia department, New Civil Hospital, Majura Gate, Surat, Gujarat

Surat
GUJARAT
395001
India 
Phone  9925176299  
Fax    
Email  harshapad@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr HARSHA PATEL 
Designation  Additional Professor 
Affiliation  New Civil Hospital, Goverment medical college, Surat 
Address  No18, OPD block, Anesthesia department, New Civil Hospital, Majura Gate, Surat, Gujarat

Surat
GUJARAT
395001
India 
Phone  9925176299  
Fax    
Email  harshapad@yahoo.com  
 
Source of Monetary or Material Support  
Government Medical College and New Civil Hospital, Surat 
 
Primary Sponsor  
Name  Government Medical College and New Civil Hospital, Surat 
Address  New Civil Hospital, Majura Gate, Surat 
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 AMITHAB S R   New Civil Hospital, Surat, Gujarat  MOT, 2nd floor OT Complex, Post operative Recovery Room, Anesthesia department, New Civil Hospital, Majura Gate, Surat, Gujarat
Surat
GUJARAT 		 7034258047

amithab.pkv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics Commitee of New Civil Hospital and Government Medical College, Surat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients with ASA(American Society of Anesthesiology) Class I-III undergoing Laparoscopic Cholecystectomy under General Anesthesia
2) Patients who give informed and written consent to collect data  
 
ExclusionCriteria 
Details  1) ALDRETE SCORE <9
2) Pregnancy
3) Patients with chronic pain disorder
4) Patients with peripheral vascular diseases
5) Cases in which intraoperatively laparoscopic procedure in converted to open cholecystectomy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Perfusion index
VAS score
Heart rate
Blood pressure 		 Pre analgesic when VAS score more than 3
Post analgesic when VAS score less than 3 
 
Secondary Outcome  
Outcome  TimePoints 
Requirement of rescue analgesia  when VAS score does not come to less than 3 within 30 minutes after administration of analgesia 
 
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   N/A 
Date of First Enrollment (India)   10/06/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The International Association for the Study of Pain(IASP) defines pain as “As unpleasant sensory and emotional experience associated with actual or potential tissue damage , or described in terms of such damage’. Unrelieved postoperative pain can result in serious side effects that effect the respiratory system (atelectasis, retention of secretions, pneumonia), the cardiovascular system (hypertension, arrhythmias, coronary ischemia), the gastrointestinal system ( decreased bowel movement, nausea, vomiting) and the endocrinal system( increased catecholamine release). It also promotes thromboembolism by delaying mobilization. Reducing pain during surgery and preventing and managing pain postoperatively is of crucial importance in the perioperative period. The objective of pain management are to measure the severity of pain, select the appropriate analgesic and estimate the response to treatment. Pain is subjective symptom thus emotional and psychological factors may interfere with its assessment. The visual analogue score (VAS) and Numeric Rating Scale are the most common pain assessment tools used. However there are still cases of pain that remain unresolved or undertreated because the patients were unable to express themselves adequately, such as in patients with mental retardation or dementia or unconscious patients in ICUs. Perfusion index is an indirect, non invasive and continuous measure of peripheral perfusion. It is calculated by the relation between pulsatile and static blood in peripheral tissues. The changes in sympathetic nervous tone affect smooth muscle tone and can alter the level of perfusion.. Most anesthetics produce a vasodilatory effect while pain produce vasoconstriction. The PI may decrease due to increased vasomotor tone and the contraction of peripheral blood vessels when sympathetic nervous system is activated by pain. Use of adequate analgesic abolishes sympathetic stimulation and perfusion increases which may result in increased perfusion index. Few studies have been done to evaluate PI as a tool for postoperative pain assessment. So we plan to correlate PI and VAS score for pain of post operative patients to test if the perfusion index is a useful marker for objective assessment of pain management in the PACU.  
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