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CTRI Number  CTRI/2025/09/095166 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 20/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   local Anaesthesia infiltration or block at surgical incision site to minimize stress response of surgery in general anaesthesia : Randomized control study 
Scientific Title of Study   PREEMTIVE ANALGESIA TO ATTENUATE PEERIOERATIVE STRESS RESPONSE OF SURGERY IN GENERAL ANAESTHESIA : RANDOMISED CONTROLLED 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 Yadav 
Designation  Senior Consultant NBEMS and Associate Professor 
Affiliation  VCSGGIMS and RESEARCH associated HNB BASE TEACHING HOSPITAL 
Address  Office Dept of Anaesthesiology and CRITICAL CARE VCSGGIMS and Research Srinagar Garhwal Uttarakhand
Office Dept of Anaesthesiology and Critical Care VCSGGIMS and Research Srinagar Garhwal Uttarakhand
Garhwal
UTTARANCHAL
246174
India 
Phone  9410110479  
Fax    
Email  satyendra.homein@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Satyendra Yadav 
Designation  Senior Consultant NBEMS and ASSOCIATE PROFESSOR 
Affiliation  VCSGGIMS and RESEARCH associated HNB BASE TEACHING HOSPITAL 
Address  Office Dept of Anaesthesiology and Critical Care VCSGGIMS and Research Srinagar Garhwal Uttarakhand
Office Dept of Anaesthesiology and Critical Care VCSGGIMS and Research Srinagar Garhwal Uttarakhand

UTTARANCHAL
246174
India 
Phone  9410110479  
Fax    
Email  satyendra.homein@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Satyendra Yadav 
Designation  Senior Consultant NBEMS and ASSOCIATE PROFESSOR 
Affiliation  VCSGGIMS and RESEARCH associated HNB BASE TEACHING HOSPITAL 
Address  Office Dept of Anaesthesiology and Critical Care VCSGGIMS and Research Srinagar Garhwal Uttarakhand
Office Dept of Anaesthesiology and Critical Care VCSGGIMS and Research Srinagar Garhwal Uttarakhand

UTTARANCHAL
246174
India 
Phone  9410110479  
Fax    
Email  satyendra.homein@gmail.com  
 
Source of Monetary or Material Support  
VCSG Govt Institute of Medical Sciences and Research Srinagar Garwhal Uttarakhand Pin Code 246174 India 
 
Primary Sponsor  
Name  VCSG Govt Institute of Medical Sciences and Research 
Address  VCSG Govt Institute of Medical Sciences and Research Srinagar Garhwal pin Code 246174 Uttarakhand India 
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 Satyendra Yadav  VCSG Govt Institute of Medical Sciences and Research  Department of Anaesthesia and Critical Care Office Veer Chandra Singh Garhwali Govt Institute of Medical Sciences and Research
Garhwal
UTTARANCHAL 		 9410110479

satyendra.homein@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Veer Chandra Singh Garhwali govt institute of Medical Sciences and Reseach  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H679||Otitis media in diseases classified elsewhere, unspecified ear,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  patients undergoing surgery in General Anaesthesia without preemptive analgesia Group A  patients undergoing typmpanoplasty mastoidectomy under General Anaesthesia without preemptive analgesia  
Intervention  preemptive analgesia Group B  local infiltration nerve block of injection Bupivacaine 0.5% in dose of 3mg/kg upto 15 ml volume of drug at surgical inscion site in patients undergoing tympanoplasty mastoidectomy under general anaesthesia in ASA grade 1 patients. 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  ASA GRADE1 patients with Chronic otitis media undergoing TYMPANOPLASTY under GENERAL ANAESTHESIA.
Weight above 40kg 
 
ExclusionCriteria 
Details  ASA 2, 3,4,
Weight below 40kgs
patients allergic to bupivacaine.
patients on Beta blockers or other antihypertensive drugs 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study effect of pre-emptive analgesia on hypothalamic pituitary adrenal neuroendocrinal stress response axis during perioperative period by measuring levels of blood adrenaline , cortisol and glucose in patient undergoing surgery in general anaesthesia  Stress response evaluated measuring Serum Adrenaline, Cortisol and Blood Glucose level at Basal Level, 10 mins post intubation, 3 mins post incision , 63 mins post incision, 123 mins post incision and 1hr after extubation.  
 
Secondary Outcome  
Outcome  TimePoints 
To corelate perioperatiove stress response with haemodynamic clinical parameters of Blood pressure , Mean arterial pressure heart rate
Visual analogue score at end of surgery after extubation. 		 Heart Rate Blood Pressure Mean arterial pressure Temperature monitoring will be done at Basal level, followed by every 2 mins after endotracheal intubation during perioperative period till the end of surgery.

Analyse Visual Analogue Scale at end of surgery every 10 minutes after Extubation upto 1hr. 
 
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)   17/10/2025 
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="15" 
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  

AIM To study preemptive analgesia to attenuate surgical stress response in General Anaesthesia during perioperative period

RATIONAL

 Surgical stimulus result in neuroendocrinal catabolic and inflammatory immune stress response which is harmful to the patient

        General anaesthesia does not block surgical stimulus afferent pathway, therefore stress response persist even after  general anaesthesia through hypothalamus pituitary adrenal axis

        Local anaesthetic agent in form of nerve block local infiltration or regional anaesthesia block afferent pathway to hypothalamus pituitary adrenal axis and thus surgical stress response 

        Preemptive analgesia in form of local anaesthetic infiltration Nerve block  at surgical site along with general anaesthesia  blocks afferent nerve signal to central hypothalamic pituitary adrenal axis completely

We hypothesized that preemptive analgesia is likely to block surgical stress during general anaesthesia by blocking the afferent pathway to hyothalamus pituitary adrenal axis which is measured by levels of adrenaline, cortisol and blood sugar levels

Patient diagnosed with  Chronic Suppurative Otitis Media with blood investigation Within normal limit

ASA grade I  Male patients  undergoing tympanoplasty mastoidiectomy in general anaesthesia Randomised in two group  A and B with chitbox method 

AGE 18 to 60 years 40 Kg and above

Group A CONTROL   General anaesthesia

Group B  STUDY General anaesthesia with local infiltration and post auricular nerve block

Sample site  VCSG department of anaesthesia

Blinding Double blind Patient and investigator will be blinded 

Patient will be given General anaesthesia as routine

Premedication  midazolam 0.05mgper kg glycopyrrolate 0.2mg Fentanyl  2 mcg per kg  Inj Paracetamol 15mg per Kg less than 50 Kg and 1g more 50kg over 10 minutes

10 percentage lignocaine spray  6 puff 60 mg in oropharyngeal airway with deep inhalation to attenuate endotracheal intubation response.

 

Induction with propofol 2mg per kg  followed by endotracheal intubation

Maintenance with nitrous oxide sevoflurane and vecuronium

EtCO2 35 to 40 mmhg

 

PREEMTIVE ANALGESIA

DRUG BUPIVACAINE 0.5percentage  3mg per Kg Volume   15  ml Local infiltration Pre   post auricular and aural canal  areas after General anaesthesia before surgical incision 

 Postauricular auriculotemporal 5 Nr Branch   Vagus and glassophyrngeal

 

Blood investigation  Adrenaline Cortisol blood sugar level

Timing of sample 

  1. Basal  In preoperative area

  2. 3 mins after  incision

  3. 63 mins after incision

  4. 123 mins after incision

  5. 1 hr after extubation

 

    Heart Rate  Blood Pressure Mean arterial pressure Temperature monitoring Basal, 10 mins after intubation and 3 mins after incision and every 10 mins upto 1hr post extubation

To analyze Visual Analogue Scale at end of surgery  10 minutes after Extubation

 
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