| 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 |
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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.
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| 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 |
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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] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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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 |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, (2) ICD-10 Condition: N186||End stage renal disease, |
|
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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 |
|
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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 |
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Double Blind Double Dummy |
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Primary Outcome
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| 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. |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Intra operative hemodynamics, post operative nausea vomiting and recovery. |
Post operative recovery time. |
|
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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" |
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Phase of Trial
|
Phase 4 |
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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 |
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Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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. |