| CTRI Number |
CTRI/2024/04/066139 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing safety and efficacy of Erector Spinae Plane Block vs Quadratus Lumborum Block in patients undergoing PCNL surgery |
|
Scientific Title of Study
|
Comparison of safety and efficacy of Erector Spinae Plane Block vs Quadratus Lumborum Block for post operative analgesia in patients undergoing Percutaneous Nephrolithotomy A Randomized control trial |
| 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 Sniya |
| Designation |
Junior Resident |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Room no 56, Division 1,
Junior Resident
Department of Anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital Pondicherry
Pondicherry PONDICHERRY 605107 India |
| Phone |
8547032890 |
| Fax |
|
| Email |
sniyasurendran56@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suneeth P Lazarus |
| Designation |
HOD and Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
HOD and Professor
Room no: 1, Division 1,
Department of Anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital Pondicherry
Pondicherry PONDICHERRY 605107 India |
| Phone |
9894332543 |
| Fax |
|
| Email |
lazarus.suneeth@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Suneeth P Lazarus |
| Designation |
HOD and Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
HOD and Professor
Department of Anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital Pondicherry
Pondicherry PONDICHERRY 605107 India |
| Phone |
9894332543 |
| Fax |
|
| Email |
lazarus.suneeth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Pondicherry 605107, India |
|
|
Primary Sponsor
|
| Name |
Dr Sniya |
| Address |
Junior Resident
Department of Anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital Pondicherry |
| Type of Sponsor |
Other [Self] |
|
|
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 Suneeth P Lazarus |
Sri Manakula Vinayagar Medical College and Hospital |
Room no 56, Divison 1,
Sri Manakula Vinayagar Medical College and Hospital
Pondicherry India 605107 Pondicherry PONDICHERRY |
9894332543
lazarus.suneeth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH ETHICS COMMITTEE |
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 |
| Intervention |
Erector Spinae Plane Block |
Comparing the safety and efficacy of erector Spinae Plane Block and Quadratus Lumborum Block for post operative period in PCNL surgeries using 20 ml of 0.25% BUPIVACAINE |
| Comparator Agent |
Quadratus Lumborum Block |
Comparing the safety and efficacy of erector Spinae Plane Block and Quadratus Lumborum Block for post operative period in PCNL surgeries using 20 ml of 0.25% BUPIVACAINE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult age group 20 to 70 years
ASA PS I II III
Patients posted for elective PCNL |
|
| ExclusionCriteria |
| Details |
Age group below 20 years and above 70 years
Patients with ASA PS IV
BMI above 35
Patients with cognitive disability |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time duration of analgesia between Erector Spinae Plane Block and Quadratus Lumborum Block using visual analogue score |
0 minutes, 30 minutes, 60 minutes, 1.5 hours, 3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for first rescue analgesia |
0 minutes, 30 minutes, 60 minutes, 1.5 hours, 2 hours |
| Tramadol consumption in 24 hours hours |
0 minutes, 30 minutes, 60 minutes, 1.5 hours, 2 hours |
| Paracetamol consumption in 24 hours |
0 minutes, 30 minutes, 60 minutes, 1.5 hours, 2 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 |
|
Date of First Enrollment (India)
|
22/05/2024 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Percutaneous nephrolithotomy (PCNL) is one of the commonly done surgery for treating kidney stones. But the post operative pain is intense that it requires lot of analgesics. Especially in a patient with kidney disease these drugs should be used with caution. Hence nerve blocks were tried which provides commendable analgesia and thereby reducing analgesics consumption. Erector Spinae Plane Block and Quadratus Lumborum Block are two techniques that provide excellent post operative analgesia for PCNL surgeries. Though they were individually studied and proved efficacy, they are not compared and studied adequately. So we designed this study to compare the safety and efficacy of these two techniques. Bupivacaine which is a long acting amide local anaesthetic will be used for giving blocks. We will be administering 0.25% BUPIVACAINE 20 ml in both of the techniques. The study population will be selected according to the inclusion and exclusion criteria. Those who fulfils the criteria will be eligible to participate in the study. The patient and attenders will be explained about the procedure and how to give response during the study. After obtaining consent participants will be recruited to study. As per the plan of study,An experienced anaesthesiologist will be administering the block at the end of PCNL surgery,and he/she will be monitored for the next 24 hours for the duration of analgesia and also will be monitored for the complications. As the procedure is done under USG guidance,occurrence of complications is extremely minimal,however we will be prepared for the same. At the end of the study we hope we will be able to come to a conclusion whether ESPB or QLB provide better analgesia with fewer side effects and hence can be used for the improved patient care . |