| CTRI Number |
CTRI/2023/09/058021 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
23/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two approaches of nerve block for pain relief after kidney stone removal surgery. |
|
Scientific Title of Study
|
Comparative Randomized study of Erector Spinae Plane Block (ESPB) v/s Quadratus Lumborum Block (QLB) for post-operative analgesia in patients undergoing Percutaneous Nephrolithotomy (PCNL) surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1286-2911 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankit Verma |
| Designation |
Junior Resident |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 204
Department Of Anaesthesia
Teerthanker Mahaveer Medical College and Research Centre
N.H.-24, Delhi Road, Moradabad - 244001, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8906658596 |
| Fax |
|
| Email |
v3rma.ankit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Kumar Prasad |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 204
Department Of Anaesthesia
Teerthanker Mahaveer Medical College and Research Centre
N.H.-24, Delhi Road, Moradabad - 244001, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Kumar Prasad |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 204
Department Of Anaesthesia
Teerthanker Mahaveer Medical College and Research Centre
N.H.-24, Delhi Road, Moradabad - 244001, Uttar Pradesh
Ambedaker Nagar
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College and Research Centre, Moradabad, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and research Centre |
| Address |
Teerthanker Mahaveer Medical College and Research Centre,
N.H.-24, Delhi Road, Moradabad - 244001, Uttar Pradesh |
| 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 |
| Ankit Verma |
Teerthanker Mahaveer Medical College and Research Centre |
Room no 4,Department of Anaesthesia
Moradabad
UTTAR PRADESH |
8906658596
v3rma.ankit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthanker Mahaveer University-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane Block (ESPB) |
Group E will receive ultrasound guided ESPB after completion of surgery with 10 cm echogenic needle and 30 ml 0.25% bupivacaine will be injected.
The intervention will be performed once and VAS, Heart rate , Blood pressure will be recorded at time intervals of 0, 1, 2, 3, 4, 5, 6, 12, 18, 24 Hrs |
| Comparator Agent |
Quadratus Lumborum Block (QLB) |
Group Q will receive ultrasound guided QLB after completion of surgery with 10 cm echogenic needle and 30 ml 0.25% bupivacaine will be injected. The intervention will be performed once and VAS, Heart rate , Blood pressure will be recorded at time intervals of 0, 1, 2, 3, 4, 5, 6, 12, 18, 24 Hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient given informed and written consent
2) ASA physical status I-II
3) Body mass index 18.5-22.9 kg/m2
|
|
| ExclusionCriteria |
| Details |
1) Bleeding disorders
2) Skin lesions at site
3) Infections at site of proposed needle insertion
4) Allergic to local anaesthetics
5) Patient converted to GA intraoperatively
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS (Visual Analogue Score) |
0, 1, 2, 3, 4, 5, 6, 12, 18, 24 Hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamics (Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean arterial pressure, SPO2) |
0, 15, 30, 45, 60, 90 Mins
2,3,4,5,6,12,18,24 Hrs |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
07/10/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After getting approval from Institutional Ethical Committee (IEC), those patients who are fit in inclusion criteria will be included in our study.
Two groups both including 35 patients will be created and randomization will be done using chit and box method Group E will undergo ESPB, Group Q will undergo QLB
Spinal anaesthesia will be given as per the institution’s protocol.
After surgery, QLB or ESPB will be performed under the guidance of a ultrasound machine (curvilinear probe) with 10 cm echogenic needle and 30 ml 0.25% bupivacaine will be injected.
The patient will be shifted to PACU and standard analgesia (1 gm PCM 8 hrly i/v) will be given as per standard institute protocol.
VAS score and haemodynamic parameter will be assessed at the end of surgery every hr for the first 6hrs then after12hrs, 18hrs, and 24hrs. VAS >4 will be given rescue analgesia in form of I/V tramadol (1.5mg/kg). Total rescue analgesic consumption in 24 hrs and complications will be noted.
Data will be analyzed using the appropriate statistical method. |