| CTRI Number |
CTRI/2024/07/069887 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A scientific study to compare the two methods of ultrasound guided quadratus lumborum block for post-operative pain reduction in patients coming for unilateral inguinal hernia surgeries. |
|
Scientific Title of Study
|
A comparative study between two approaches of Ultrasound-guided posterior quadratus lumborum block and ultrasound guided transmuscular quadratus lumborum block for postoperative pain control in patients undergoing unilateral inguinal hernia surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Titiksha Hombanna |
| Designation |
Pg student, Anesthesiology |
| Affiliation |
Mysore medical College and Research institute |
| Address |
Mysore medical college and research institute Department of
anaesthesia,1st floor,room no.1, new stone building, Kr hospital, Irwin road,Mysore
KARNATAKA
570001
India
Mysore
KARNATAKA
570001
India |
| Phone |
9980487703 |
| Fax |
|
| Email |
titikshahombanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
V Y Srinivas |
| Designation |
Professor and HOD, Department of anesthesiology |
| Affiliation |
Mysore medical College and Research institute |
| Address |
Mysore Medical College and Research Institute,Irwin Road
Mysore
KARNATAKA
570001
India
Mysore
KARNATAKA
570001
India |
| Phone |
9353837014 |
| Fax |
|
| Email |
drsrinivasvy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
V Y Srinivas |
| Designation |
Professor and HOD, Department of anesthesiology |
| Affiliation |
Mysore medical College and Research institute |
| Address |
Mysore Medical College and Research Institute,Irwin Road
Mysore
KARNATAKA
570001
India
Mysore
KARNATAKA
570001
India |
| Phone |
9353837014 |
| Fax |
|
| Email |
drsrinivasvy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mysore medical College and Research institute, Irwin road,next to railway station, Mysore,570001 |
|
|
Primary Sponsor
|
| Name |
Mysore medical College and Research institute |
| Address |
Irwin road, next to railway station, Mysore 570001
Karnataka
India |
| Type of Sponsor |
Government 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 Titiksha Hombanna |
Krishna rajendra hospital |
Mysore medical college and research institute, department of anesthesia, 1st floor, room no 1, new stone building, KR hospital, mysore.
Irwin road, mysore,
Mysore
KARNATAKA |
9980487703
titikshahombanna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mysore Medical college and Research Institute and associated hospitals, mysore |
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 |
Post-operative ultrasound-guided QLB-2 block |
Ultrasound-guided QLB-2 block will be given postoperatively once, with 20ml of Inj 0.25%bupivacaine + 8mg of dexamethasone using 20G spinal needle in the intermucular plane between quadratus lumborum and latissimus dorsi and followed up for 24 hours for assessing post-operative pain control. |
| Comparator Agent |
Post-operative ultrasound-guided QLB-3 block |
Ultrasound-guided QLB-3 block will be given postoperatively once, with 20mlmof Inj. 0.25%bupivacaine + 8mg of dexamethasone using 20G spinal needle in the intermuscular plane between quadratus lumborum and pectoralis major and followed up for 24 hours for assessing post-operative pain control. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All ASA I and II patients undergoing unilateral inguinal hernia surgeries |
|
| ExclusionCriteria |
| Details |
All ASA III and IV patients.
Patients with comorbid conditions like diabetes, hypertension, cardiovascular, respiratory and neurological disorders, cerebrovascular insufficiency, coagulation abnormalities, renal or hepatic insufficiency.
Obesity.
Drug allergy and allergy to local anesthetics.
Patient refusal for consent.
Infection at the injection site.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time taken for first rescue analgesia between 2 approaches of USG guided quadratus lumborum block in patients undergoing unilateral inguinal hernia surgeries |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of technique and level of sensory block achieved and total analgesics consumption between 2 approaches of USG guided quadratus lumborum block |
24 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/ Phase 3 |
|
Date of First Enrollment (India)
|
12/07/2024 |
| 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="1"
Months="6"
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
|
This is a prospective randomized comparative study between ultrasound guided posterior quadratus lumborum block and transmuscular quadratus lumborum block for postoperative pain control in patients undergoing unilateral inguinal hernia surgeries in K R Hospital ,in which time for first rescue analgesia and duration of technique of both the approaches. |