| CTRI Number |
CTRI/2025/11/097196 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of ESP with peri tubal infiltration of ropivacaine for post operative analgesia in PCNL surgeries. |
|
Scientific Title of Study
|
Comparison Of Peritubal Infiltration and USG guided Erector spinae Plane block for Post operative Analgesia in Percutaneous Nephrolithotomy -A prospective randomised controlled study |
| 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 D Tulja Bhavani |
| Designation |
post -graduate |
| Affiliation |
Rajarajeswari medical college and Hospital |
| Address |
Department of Anesthesiology,Rajarajeswari medical college and hospital,mysore road,Kambipura bengaluru
Department of Anesthesiology,Rajarajeswari medical college and hospital,mysore road,Kambipura bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9908164440 |
| Fax |
|
| Email |
tdhaduvai@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Petkar |
| Designation |
Professor |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Department of Anesthesiology. Rajarajeswari Medical college and Hospital, Mysore Road, Kambipura, Bengaluru.
Department of Anesthesiology. Rajarajeswari Medical college and Hospital, Mysore Road, Kambipura, Bengaluru.
Bangalore
KARNATAKA
560074
India |
| Phone |
7726899533 |
| Fax |
|
| Email |
jokiran2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Petkar |
| Designation |
Professor |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Department of Anesthesiology, Rajarajeswari Medical college and Hospital, Mysore Road, Kambipura, Bengaluru.
Department of Anesthesiology, Rajarajeswari Medical college and Hospital, Mysore Road, Kambipura, Bengaluru.
Bangalore
KARNATAKA
560074
India |
| Phone |
7726899533 |
| Fax |
|
| Email |
jokiran2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari medical college and hospital ,Mysore Raod,kambipura, bengaluru, Karnataka, 560074 India |
|
|
Primary Sponsor
|
| Name |
Dr D Tulja Bhavani |
| Address |
Department of Anesthesiology. Rajarajeswari Medical college and Hospital, Mysore Road,
Khambipura, 560074 Bengaluru India. |
| Type of Sponsor |
Private medical college |
|
|
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 DTulja Bhavani |
Rajarajeswari medical college and Hospital |
Department of Anesthesiology, RajaRajeswari medical college and hospital, Khambipura bengaluru, 560074
Bangalore
KARNATAKA |
09908164440
tdhaduvai@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Rajarajeswari Meducal college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N22||Calculus of urinary tract in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group E -USG guided erector spinae block with 20ml of 0.375% 20 ml Ropivacaine
Group L- peritubal infiltration of 20ml 0.375% bupivacaine. |
Erector spinae block is given with 0.375% 20 ml Ropivacaine under ultrasound guidance ideally acts for around 24 hours. |
| Comparator Agent |
Group L- Peritubal infiltration of 20ml of 0.375% ropivacaine |
To assess the VAS score for post operative analgesia after PCNL surgeries acts for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA-1and ASA-2patients of either sex
2. Patients of age between 18-60years of age
3. Patients posted for elective percutaneous nephrolithotomy under general
Anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Patients with known hypersensitivity to known local Anesthetic drug
3.Patients with bleeding diathesis , uncontrolled diabetes mellitus and severe hepatorenal disease .
4. Patients with epilepsy and mentally unstable patients
5.Pregnant and lactating women
6. Patients on chronic analgesic therapy and anticoagulants.
7. Patients with cardio respiratory, neurological or psychiatric illness.
8. Renal stones which require more than one puncture , supra coastal puncture intraoperative excessive bleeding
9.Surgical time more than 3hours
10.BMI morethan 35Kg/m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the need for first rescue analgesia in both groups- in patients receiving 0.375% Ropivacaine vs patients receiving peri tubal infiltration. |
at 0,2,4,6,8,10,12,16,18
and 24hours in both groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the total analgesic consumption |
at 0,2,4,6,8,10,12,16,18 till 24 hours |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/11/2025 |
| 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
|
The primary aim of this study is to assess the VAS scores in population receiving 20ml of 0.375% Ropivacaine in erector spinae block versus population receiving 20ml of 0.375% Ropivacaine through peritubal infiltration in PCNL surgeries for post operative analgesia, to measure and compare the total analgesic consumption in both the groups. |