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CTRI Number  CTRI/2025/09/094537 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of lignocaine infusion during surgery on fentanyl consumption after surgery in renal transplant patients 
Scientific Title of Study   EFFECT OF INTRAOPERATIVE 2 PERCENTAGE LIGNOCAINE INFUSION ON POSTOPERATIVE FENTANYL CONSUMPTION IN RENAL TRANSPLANT RECIPIENTS: A RANDOMIZED, DOUBLE BLIND, PLACEBO 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 Rashmi Jain 
Designation  Senior consultant 
Affiliation  Sir Ganga Ram Hospital, New Delhi  
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram hospital, New Delhi-110060, INDIA

Central
DELHI
110060
India 
Phone  9810645865  
Fax    
Email  write2rashmi@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rashmi Jain 
Designation  Senior consultant 
Affiliation  Sir Ganga Ram Hospital, New Delhi  
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram hospital, New Delhi-110060, INDIA

Central
DELHI
110060
India 
Phone  9810645865  
Fax    
Email  write2rashmi@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jagriti Gaur 
Designation  Post diploma DNB trainee  
Affiliation  Sir Ganga Ram Hospital, New Delhi  
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram hospital, New Delhi-110060, INDIA

Central
DELHI
110060
India 
Phone  9625255830  
Fax    
Email  gaurjagriti@gmail.com  
 
Source of Monetary or Material Support  
Sir Ganga Ram Hospital, New Delhi  
 
Primary Sponsor  
Name  Sir Ganga Ram Hospital, New Delhi 
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, 5th Floor SSRB Block D, SGRH, Old Rajinder Nagar, Delhi 110060 Sir Ganga Ram hospital, New Delhi-110060, INDIA  
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 Rashmi Jain  Sir Ganga Ram Hospital  OT 12, 7th Floor SSRB Block D, SGRH, Old Rajinder Nagar, Delhi 110060 Sir Ganga Ram hospital, New Delhi-110060, INDIA
Central
DELHI 
9810645865

write2rashmi@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Sir Ganga Ram Hospital  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.9% normal saline   0.9% normal saline infusion during surgery to see postoperative fentanyl consumption in renal transplant recipient 
Comparator Agent  2% LIGNOCAINE  2% LIGNOCAINE infusion during surgery to see postoperative fentanyl consumption in renal transplant recipient 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Males or Females
2. Age: 18-65 years
 
 
ExclusionCriteria 
Details  1. Failure to obtain Consent
2. History of lignocaine sensitivity
3. LVEF less than 50%
4. ASA IV (American Society of Anaesthesiology grade IV)

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Cumulative fentanyl consumption   postoperatively first 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. Intraoperative hemodynamic parameters.
2. Adverse effects like nausea and vomiting within 2 hours, postoperative
 
intraoperative hemodynamic parameters during intraoperative period every 15 minutes
nausea and vomiting within 2 hours postoperatively 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   06/10/2025 
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="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  

Chronic kidney disease is defined as decreased glomerular filtration rate (GFR) less than 60ml/min/1.73m2 for three months or more. The best available therapeutic option for the patient’s long-term survival is renal transplantation. Renal transplantation is associated with moderate to severe postoperative pain requiring effective pain management. Perioperative 2% lignocaine infusion has been used for post operative pain relief, however very little evidence is available for its use in renal transplant patients.

The study aims to evaluate the impact of 2% lignocaine infusion on reducing fentanyl consumption in this patient population in the postoperative period. By reducing opioid consumption, lignocaine infusion may provide a useful adjunct to standard anaesthesia and pain management, leading to improved patient outcomes.

In this double-blind randomized trial, we will enrol 50 patients, 25 patients in two groups scheduled for elective renal transplant surgery. Participants will be randomly assigned into two groups: Group A will be receiving 2% lignocaine 1.5mg/kg bolus dose at induction followed by infusion 1.5mg/kg/hr till renal reperfusion, Group B will be receiving normal saline at the same rate and same volume in patient undergoing renal transplant surgery. Post- surgery, patients will receive patient-controlled analgesia (PCA) with fentanyl and cumulative fentanyl consumption will be recorded within 24 hours period.

This study hypothesizes that 2% lignocaine infusion will decrease fentanyl consumption by 30%, post operatively in renal transplant recipients.

If proven effective, these results could justify the use of lignocaine as an adjunct to renal transplant protocols, ultimately enhancing patient safety and improving postoperative recovery.   
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