| CTRI Number |
CTRI/2025/08/092850 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study To Compare The Transversus Abdominis Plane Block and Erector Spinae Plane Block in Minimally Invasive Nephrectomy Surgeries |
|
Scientific Title of Study
|
A Randomoised,Prospective, Double Blinded Study To Compare The Efficacy Of Ultrasound Guided Transversus Abdominis Plane Block and Erector Spinae Plane Block in Minimally Invasive Nephrectomy Surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shanmugapriya g |
| Designation |
STUDENT |
| Affiliation |
SRM INSTITUTES FOR MEDICAL SCIENCES |
| Address |
A Block,21,DEPARTMENT OF ANAESTHESIOLOGY,NO 1 ,JAWAHARLAL NEHRU SALAI,
VADAPALANI, CHENNAI, TAMIL
NADU
Chennai
TAMIL NADU
600026
India |
| Phone |
6382766629 |
| Fax |
|
| Email |
gopalakrishnanshanmugapriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Thiyagarajan s |
| Designation |
SENIOR CONSULTANT, DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
SRM INSTITUTES FOR MEDICAL SCIENCES |
| Address |
A BLOCK ,21, DEPARTMENT OF ANAESTHESIOLOGY,NO 1 ,JAWAHARLAL NEHRU SALAI,
VADAPALANI, CHENNAI, TAMIL
NADU
Chennai
TAMIL NADU
600026
India |
| Phone |
9790930134 |
| Fax |
|
| Email |
anaes1879@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
shanmugapriya g |
| Designation |
STUDENT |
| Affiliation |
SRM INSTITUTES FOR MEDICAL SCIENCES |
| Address |
A BLOCK,21,DEPARTMENT OF ANAESTHESIOLOGY,NO 1 ,JAWAHARLAL NEHRU SALAI,
VADAPALANI, CHENNAI, TAMIL
NADU
Chennai
TAMIL NADU
600026
India |
| Phone |
6382766629 |
| Fax |
|
| Email |
gopalakrishnanshanmugapriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Institutes For
Medical Sciences,NO 1
JAWAHARLAL NEHRU SALAI,
VADAPALANI, CHENNAI, TAMIL
NADU, 60002 |
|
|
Primary Sponsor
|
| Name |
SRM Institutes For Medical Sciences |
| Address |
NO 1
Jawaharlal Nehru Salai,
Vadapalani,Chennai,TamilNadu, 60002 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 SHANMUGAPRIYA G |
SRM INSTITUTES FOR MEDICAL SCIENCES, |
DEPARTMENT OF ANAESTHESIOLOGY,NO 1
JAWAHARLAL NEHRU SALAI,
VADAPALANI,CHENNAI,TAMIL
NADU, 600026
Chennai
TAMIL NADU |
06382766629
gopalakrishnanshanmugapriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM INSTITUITIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERECTOR SPINAE PLANE BLOCK |
To compare The Efficacy of Erector Spinae Plane Block In Minimally Invasive Nephrectomy Surgeries |
| Intervention |
Transversus Abdominis Plane Block |
To compare The Efficacy of Transversus Abdominis Plane BlockIn Minimally Invasive Nephrectomy Surgeries |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA grade 1 and 2,Any gender ,Age 20 to 70 years ,BMI 18 to 30 ,Patients willing to participate in the study ,Patients admitted for minimally invasive nephrectomy surgery ,No history of allergy to Local anaesthetics
|
|
| ExclusionCriteria |
| Details |
1)ASA grade 3, 4, 5,Pregnant and lactating mother,Age less than 20 years and more than 70 years,Obese individuals with BMI more than 30,Chronic history of Opioid abuse,History of allergy to Local anaesthetics,Patients not willing to participate in this study
|
|
|
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 |
| 1)To observe intraoperative Remifentanil requirement and the pain score using Visual Analog Scale (VAS) score for first 24 hours,postoperative Tramadol requirement for first 24 hours |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To observe the incidence of hemodynamic disturbances during perioperative period
2) To observe the incidence of side effects of opioids such as postoperative nausea, vomiting, sedation and respiratory depression
|
12 months |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/08/2025 |
| 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
|
This study is a randomised ,prospective,double blinded comparing the efficacy of ultrasound guided Transversus Abdominis Plane Block and Erector Spinae Plane Block in Minimally Invasive Nephrectomy Surgeries.Primary outcomes will be intraoperative Remifentanil requiremet,the pain score using Visual Analog Scale (VAS) score for first 24 hours,the postoperative Tramadol requirement for first 24 hours.secondary outcomes will be the incidence of hemodynamic disturbances during perioperative period,the incidence of side effects of opioids such as postoperative nausea, vomiting, sedation and respiratory depression. |