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CTRI Number  CTRI/2025/03/081658 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
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   A study to evaluate post operative pain relief in renal transplant recipient patients  
Scientific Title of Study   A RANDOMIZED CONTROL STUDY TO EVALUATE THE EFFICACY OF INTRAOPERATIVE LIGNOCAINE INFUSION FOR POST-OPERATIVE PAIN RELIEF IN RENAL TRANSPLANT RECIPIENT PATIENTS.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangeetha A 
Designation  DNB Anaesthesia resident 
Affiliation  Manipal hospitals  
Address  2nd floor, Department of anaesthesia, Manipal hospital, Old airport road, Bangalore.

Bangalore
KARNATAKA
560017
India 
Phone  9786031501  
Fax    
Email  Shobiashok@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jalaja KR 
Designation  senior consultant of anesthesiology 
Affiliation  Manipal hospitals  
Address  2nd floor, Department of anaesthesia Manipal hospital, Old airport road, Bangalore.

Bangalore
KARNATAKA
560017
India 
Phone  9786031501  
Fax    
Email  jalaja1975@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sangeetha A 
Designation  DNB Anaesthesia resident 
Affiliation  Manipal hospitals  
Address  2nd floor, Department of anaesthesia Manipal hospital, Old airport road, Bangalore.

Bangalore
KARNATAKA
560017
India 
Phone  9786031501  
Fax    
Email  Shobiashok@gmail.com  
 
Source of Monetary or Material Support  
Manipal hospitals,Old airport road, Bangalore, India - 560017 
 
Primary Sponsor  
Name  Sangeetha A 
Address  Manipal hospital, old airport road, Bangalore, India - 560017 
Type of Sponsor  Other [self] 
 
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 
Sangeetha A  Manipal hospitals  Department of anaesthesia, 2nd floor, Old airport road Bangalore 560017
Bangalore
KARNATAKA 
9786031501

Shobiashok@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of Manipal hospital, Bnaglore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease, (2) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous lignocaine  Intravenous lignocaine infusion at the rate of 1.5mg/kg/hour from induction to skin closure 
Comparator Agent  Normal saline 0.9%  Intravenous normal saline infusion at the rate of 3-5 ml/kg/hr from induction to skin closure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. End stage renal disease patients undergoing recipient of elective live renal transplant surgery
2. Ages 18-65
3. Genders - male and female
4. ASA 2 and ASA 3 patients 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Allergic to lignocaine
3. Age less than 18 and more than 65
4. ASA 4 patients
5. Patients undergoing cadaver in renal transplants
6. Uncontrolled Hypertension and Diabetes Mellitus
7. Deranged liver function tests
8. NYHA III and IV
9. History of convulsions 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of intravenous lignocaine at 1.5 mg/kg/hr. in giving adequate post-operative pain relief in renal transplant patients by a combination of numeric pain scale and postoperative fentanyl consumption in comparison to the control group.  Intra operative surgery time and the duration of patient controlled analgesia. 
 
Secondary Outcome  
Outcome  TimePoints 
Intra operative hemodynamics, post operative nausea vomiting and recovery.  Post operative recovery time. 
 
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 4 
Date of First Enrollment (India)   15/03/2025 
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 Yet Recruiting 
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  

Renal transplants are one of the most performed transplant surgeries. The post-operative pain causes significant morbidity because of the complexity of the transplant surgery and delays the recovery period. These patients often have multiple comorbidities and with poorly controlled postoperative pain, can lead to tachycardia, hypertension, and increased risk of respiratory complications, which can in turn affect overall recovery and graft survival. Among the multimodal pain relief available for these patients, lignocaine has a good margin of safety because of its pharmacodynamics and pharmacokinetics that can make it a good sought-after drug despite the multiple co morbidities present in these patients.

Lignocaine hydrochloride is a local anesthetic agent commonly used for local and topical anesthesia, but it also has antiarrhythmic, and analgesic uses and can be used as an adjunct to tracheal intubation. It is a tertiary amine and is a class Ib antiarrhythmic agent. The anti-nociceptive effects of lignocaine are to be attributable to the blockade of neuronal sodium channels and potassium currents, and the blockade of presynaptic muscarinic and dopamine receptors. They also block sodium and potassium currents centrally at a spinal cord level, specifically targeting the spinal dorsal horn neurons, in addition to their generally accepted peripheral nerve blockade.  Lignocaine has potential utility as a potent anti-inflammatory agent. Accumulating data suggests that lignocaine’s powerful anti-inflammatory properties may be superior in many ways to non-steroidal anti-inflammatory drugs and steroids, the traditional anti-inflammatory agents.

 

With the above discussion, we can hypothesize that, “Intraoperative Lignocaine hydrochloride infusion can be used for providing post-operative pain relief to reduce the opioid consumption” and this study will test the same hypothesis.

 

 
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