| CTRI Number |
CTRI/2026/02/104832 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare ultrasound guided quadratus lumborum block and erector spinae block in patient undergoing percutaneous nephrolithotomy |
|
Scientific Title of Study
|
A study to compare ultrasound guided quadratus luborum block and erector spinae block for post operative analgesia in patient undergoing percutaneous nephrolithotomy - A prospective randomised double blind study |
| Trial Acronym |
RACE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. RAVI BHAT |
| Designation |
Professor |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL MANJUSHREE NAGAR SATTUR DHARWAD 580009 |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL MANJUSHREE NAGAR SATTUR DHARWAD KARNATAKA
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL MANJUSHREE NAGAR SATTUR DHARWAD 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9741114252 |
| Fax |
91 |
| Email |
nallaharika108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAVI BHAT |
| Designation |
PROFESSOR |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL MANJUSHREE NAGAR SATTUR DHARWAD KARNATAKA
DEPARTMENT OF ANAESTHESIOLOGY SDM COLLEGE OF MEDIAL SIENCE AND HOSPITAL MANJUSHREE NAGAR SATTUR DHARWAD KARNATAKA
Dharwad
KARNATAKA
580009
India |
| Phone |
9482181582 |
| Fax |
91 |
| Email |
kakodravi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
RAVI BHAT |
| Designation |
PROFESSOR |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL MANJUSHREE NAGAR SATTUR DHARWAD KARNATAKA
SDM COLLEGE OF MEDICAL SCIENCE AND HOSITAL MANJUSHREE NAGAR SATTUR DHARWAD KARNATAKA
Dharwad
KARNATAKA
580009
India |
| Phone |
9482181582 |
| Fax |
91 |
| Email |
kakodravi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL MANJUSHREE NAGAR SATTUR DHARWAD KARNATAKA |
| 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 |
| Nalla Harika |
SDM COLLEGE OF MEDICAL SCIENES AND HOSPITA |
DEARTMENT OF ANAESTHESIA , OT COMPEX 4( UROLOGY OT)
Dharwad
KARNATAKA |
9741114252
91
nallaharika108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP EBS |
All members of this group will receive quadratus lumborum block on side of surgery.The ESB block will be performed by using Bupivacaine 0.25%(20ml on side of surgery). VAS score will be assessed upto 24 hours postoperatively. |
| Comparator Agent |
GROUP QLB |
All members of this group will receive quadratus lumborum block on side of surgery.The QLB block will be performed by using Bupivacaine 0.25%(20ml on side of surgery). VAS score will be assessed upto 24 hours postoperatively. |
| Comparator Agent |
GROUP QLB+ESB |
GROUP QLB+ESB: Patients will be administered alternatively with Quadratous lumborum block and Erector spinae block.Post operatively patient will be kept in recovery room for 2 hours, VAS score will be assessed at 1,2,4,8,12,16 and 24 hours after procedure. time from study drug injection till first dose of rescue analgesia is considered as duration of analgesia.Total number of rescue analgesic doses in 24 hours will be recorded |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18-70 years.
ASA grade 1,2,3 Patients. |
|
| ExclusionCriteria |
| Details |
Presence of contraindication to local anaesthetic agent.
Obese patients BMI more than 30 kg per meter square.
Presence of infection at injection site. |
|
|
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 |
| Duration of post operative analgesia. |
Time point A:time from study drug injection,
Time point B:6hours after surgery.
Time point c:24hours after Time point B. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post Operative pain score. |
Time point B:6hours after surgery.
Time pointC:24hours after Time point B. |
| Total analgesic drug consumption in 24 hours. |
Time point C:24hours after time point C |
| Adverse effects |
Time point A:time from study drug injection,
Time point B:6hours after surgery.
Time point c:24hours after Time point B. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 1 |
|
Date of First Enrollment (India)
|
10/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
The ethical committee approval of the institute will be taken. Informed consent will be obtained from all the patients A prospective randomized double blind study. All the patients will undergo thorough preoperative evaluation, which include history taking, physical examination and relevant laboratory investigations. Patients having any of the exclusion criteria will be excluded from the study. Patients willing to be part of the study will be randomly allocated in to 2 groups which will be computer generated. Patient will be educated about VAS score in the pre operative visit. All patients will be informed about the potential benefits and complications after the study will be thoroughly explained. Standard monitors like pulse oximeter, ECG, and NIBP recording will be attached to all patients and baseline parameters such as pulse rate, blood pressure and oxygen saturation will be noted. Anaesthesia induction will be delivered with fentanyl 2mcg/kg, propofol 2mg/kg and vecuronium 0.1mg/kg, maintenance by isoflurane and 50% nitrous and 50%oxygen.Patient will be intubated with appropriate size endotracheal tube. Intravenous Ondansetron 4mg and Dexamethasone 4mg will be given to all the patients.. After administering general anaesthesia in supine position, the patient will be turned to lateral position. A total of 60 patients aged between 18 and 75 years. ASA grading 1, 2 and 3 will be selected allocated to 2 groups randomly- QLB Group: All members of this group will recive quadratus lumborum block on side of surgery. The QLB will performed by using bupivacaine 0.25% (20 ml on side of surgery). ESB Group: All members of this group will erector spinae block on side of surgery. The ESB was performed by using bupivacaine 0.25% (20 ml on side of surgery). Heart rate, blood pressure, oxygen saturation will be monitored every 5 min for initial 30 min and later on every 15 min till the end of surgery. Post operatively patient will be kept in recovery room for 2 hours. Heart rate, blood pressure, oxygen saturation will be measured and VAS score will be noted at 1,2, 4, 8, 12,16 and 24 hours after the procedure. If pain score ≥ 3, then patient will be given intravenous Paracetamol 1g iv (up to 3 doses /day). If pain persists after 30 minutes of paracetamol injection, then intravenous Tramadol 50mg will be given (up to 2 doses/day). Time from study drug injection till first dose of rescue analgesia is considered as duration of analgesia. Total number of rescue analgesic doses in 24 hours will be recorded. |