| CTRI Number |
CTRI/2025/07/091896 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison Of The Efficacy Of Quadratus Lumborum Type 2(QL 2) Block And Erector Spinae Plane Block(ESPB) For Post Operative Pain Relief In Unilateral Nephrectomy- A Prospective Observational Study |
|
Scientific Title of Study
|
COMPARISON OF THE EFFICACY OF QUADRATUS LUMBORUM TYPE 2(QL 2) BLOCK AND ERECTOR SPINAE PLANE BLOCK(ESPB) FOR POST OPERATIVE PAIN RELIEF IN UNILATERAL NEPHRECTOMY- A PROSPECTIVE OBSERVATIONAL 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 AMIYA KUMAR MISHRA |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
Medica superspecialty hospital |
| Address |
127, Eastern Metropolitan Bypass, Nitai Nagar, Mukundapur, Kolkata, West Bengal 700099
Kolkata
WEST BENGAL
700099
India |
| Phone |
9831847431 |
| Fax |
|
| Email |
amiya.mishra@manipalhospitals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABHIRUP NAYAK |
| Designation |
CONSULTANT |
| Affiliation |
Medica superspecialty hospital |
| Address |
127, Eastern Metropolitan Bypass, Nitai Nagar, Mukundapur, Kolkata, West Bengal 700099
Kolkata
WEST BENGAL
700099
India |
| Phone |
8902688826 |
| Fax |
|
| Email |
abhirup.nayak88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ARUN GOPAN T G |
| Designation |
FELLOW |
| Affiliation |
Medica Superspecialty hospital |
| Address |
127, Eastern Metropolitan Bypass, Nitai Nagar, Mukundapur, Kolkata, West Bengal 700099
Kolkata
WEST BENGAL
700099
India |
| Phone |
8075247614 |
| Fax |
|
| Email |
arun00784@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medica Superspecialty Hospital |
|
|
Primary Sponsor
|
| Name |
Medica Superspecialty hospital |
| Address |
127, Eastern Metropolitan Bypass, Nitai Nagar, Mukundapur, Kolkata, West Bengal 700099 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 ARUN GOPAN T G |
MEDICA SUPERSPECIALTY HOSPITAL |
127, Eastern Metropolitan Bypass, Nitai Nagar, Mukundapur, Kolkata, West Bengal 700099
Kolkata
WEST BENGAL |
8075247614
arun00784@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICAL RESEARCH ETHICS COMMITTEE MEDICA SUPERSPECIALTY HOSPITAL |
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 |
| Comparator Agent |
Ultrasound Guided Erector Spinae Plane Blco |
Local anestheric is deposited deep into erector spinae muscles and transverse process |
| Intervention |
Ultrasound Guided Quadratus Lumborum Type 2 Block |
Local anesthetic is deposited in the space between quadratus lumborum and thoracolumbar fascia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists score 1 and 2
Patients posted for laproscopic and robotic nephrectomies
|
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL
AMERICAN SOCIETY OF ANESTHESIOLOGISTS PHYSICAL STATUS 3 AND ABOVE
ALLERGY TO LOCAL ANESTHETIC DRUGS
PATIENT POSTED FOR END STAGE PALLIATIVE THERAPY, ADVANCED CANCERS
PATIENTS POSTED FOR REVISION SURGERIES
COAGULOPATHY
LOCAL INFECTION AT BLOCK SITE
PATIENTS WITH HISTORY OF OPIOID USE OR CHRONIC PAIN
PREGNANT PATIENTS
LACTATING MOTHERS
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare duration of post operative analgesia between quadratus lumborum type 2 and Erector spinae plane block |
Pain score and vitals are assessed at 0,2,6,12 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare total post operative fentanyl consumption
To assess patient satisfaction score
To monitor for block related cmplications |
Immediate post operative period & after 24 hours |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/08/2025 |
| 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
|
Comparison of efficacy of quadratus lumborum type 2 vs Erector spinae plane block to manage post operative pain in laproscopic/robotic nephrectomy patients. This is a prospective observational study where the type of intervention is not randomised but the block to be administered is determined by the attending anesthetist managing the said case. Patients pain score and vitals is observed post operatively at 0,2,6,12 and 24 hours along with patient satisfaction score by Likert scale at the end of 24 hours. |