| 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
|
|
|
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
|
|
|
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. |