| CTRI Number |
CTRI/2025/09/094943 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Erector spinae plane block along with general anaesthesia in patients posted for percutaneous nephrolithotomy surgery for assessing post-operative quality of recovery |
|
Scientific Title of Study
|
Erector spinae plane block supplementation to general anaesthesia in percutaneous nephrolithotomy surgery for post-operative quality of recovery |
| 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 Mamta Agrawal |
| Designation |
Postgraduate Student |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no 1 Department of Anaesthesiology Peoples Hospital Peoples College of Medical Science and Research Centre Bhanpur Bhopal
Peoples Hospital Peoples College of Medical Science and Research Centre Bhanpur Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9870302512 |
| Fax |
|
| Email |
dr.mamta201023@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupam Pandey |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no 2 Department of Anaesthesiology Peoples Hospital Peoples College of Medical Science and Research Centre Bhanpur Bhopal
Peoples Hospital Peoples College of Medical Science and Research Centre Bhanpur Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8889480540 |
| Fax |
|
| Email |
docanshu07@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupam Pandey |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no 2 Department of Anaesthesiology Peoples Hospital Peoples College of Medical Science and Research Centre Bhanpur Bhopal
Peoples Hospital Peoples College of Medical Science and Research Centre Bhanpur Bhopal Madhya Pradesh 462037
MADHYA PRADESH
462037
India |
| Phone |
8889480540 |
| Fax |
|
| Email |
docanshu07@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples Hospital Peoples College of Medical Science and Research Centre Bhanpur Bhopal Madhya Pradesh India 462037 |
|
|
Primary Sponsor
|
| Name |
Peoples College of Medical Sciences And Research Centre |
| Address |
Peoples Hospital Peoples College of Medical Science and Research Centre Bhanpur Bhopal Madhya Pradesh 462037 |
| 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 Mamta Agrawal |
Peoples Hospital |
Peoples Hospital Peoples College of Medical Science and Research Centre Bhanpur Bhopal
Bhopal
MADHYA PRADESH |
9870302512
dr.mamta201023@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE PEOPLES COLLEGE OF MEDICAL SCIENCE AND RESEARCH CENTRE |
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 |
| Comparator Agent |
Administering general anaesthesia alone to patients posted for PCNL surgery |
Patients posted for PCNL surgery will be given general anaesthesia alone and will be observed for post operative quality of recovery 24 hrs postoperatively and at the day of discharge |
| Intervention |
Erector spinae plane block supplementation to general anaesthesia |
Patients posted for PCNL surgery will be given erector spinae plane block using 20ml 0.25% levobupivacaine between the 2 fascia at the level of L1 vertebra 3cm lateral after administering general anaesthesia to observe the post operative quality of recovery upto 24hrs postoperatively and at the day of discharge |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA class I and II
Patients posted for elective percutaneous nephrolithotomy surgery |
|
| ExclusionCriteria |
| Details |
Patient not giving consent
Age less than 18 years and more than 60 years
ASA class III and IV
Allergic to levobupivacaine
Pregnant and lactating female
Patient with any spinal deformity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of erector spinae plane block supplementation to general anaesthesia on postoperative analgesia and time of first opioid consumption |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative quality of recovery in the two groups with the help of QoR 15 score |
At the time of discharge |
|
|
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 4 |
|
Date of First Enrollment (India)
|
27/09/2025 |
| 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="0"
Months="6"
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
|
Patients posted for elective percutaneous nephrolithotomy surgery will be divided equally into 2 groups E and C where E group patients will be administered general anaesthesia followed by erector spinae plane block with 0.25% levobupivacaine and will be observed for post-operative analgesia and time for first opioid consumption followed by assessment of post-operative quality of recovery on the day of discharge with the help of QoR 15 score. Group C patients will be administered with general anaesthesia alone and will be observed similarly. The data from both the groups will then be compared and assessed for the better outcomes. |