| CTRI Number |
CTRI/2025/09/094397 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
07/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Ultrasound guided Quadratus Lumborum block and Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy:a randomised controlled trial |
|
Scientific Title of Study
|
Comparison of Ultrasound guided Quadratus Lumborum block and Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy |
| 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. Vridhi Rajan |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Dr. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, SHAMPURA MAIN ROAD, KG HALLI, BANGALORE - 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9964059953 |
| Fax |
|
| Email |
Vridhir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vridhi Rajan |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Dr. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, SHAMPURA MAIN ROAD, KG HALLI, BANGALORE - 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9964059953 |
| Fax |
|
| Email |
Vridhir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suvina |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, KG HALLI, BENGALURU- 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
6366279888 |
| Fax |
|
| Email |
suvi11492@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE, KG HALLI, BANGALORE- 560045 |
| 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 Vridhi Rajan |
Dr B R Ambedkar Medical College |
DEPARTMENT OF ANESTHESIOLOGY, Major OT complex, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, BENGALURU- 560045, KARNATAKA
Bangalore
KARNATAKA |
9964059953
vridhir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quadratus Lumborum Block |
Ultrasound Guided trans muscular Quadratus lumborum block using 20ml of 0.2% Ropivacaine with 4mg Dexamethasone |
| Comparator Agent |
Transverse Abdominis Plane Block |
Ultrasound Guided Transverse Abdominis plane block using 20ml 0.2% Ropivacaine with 4mg dexamethasone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for elective laparoscopic cholecystectomy surgeries
2. Age 18 - 70 years
3. American Society of Anaesthesiologists (ASA) class I, II patients.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Bleeding or coagulation abnormality.
3. Local skin infection and sepsis at site of the block
4. Allergy/ Hypersensitivity to the study drugs
5. If laparoscopic cholecystectomy is converted into open cholecystectomy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post operative analgesic requirement in patients who received Ultrasoumd guided Quadratus lumborum block and Transverse abdominis plane block after laparoscopic cholecystectomy. |
every 6hrs for the first 24hrs post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Post operative Visual Analogue scale (VAS score) at 0, 6 , 12 and 24 hrs
2.Time taken to request for first dose of rescue analgesia by the patient
|
every 6hrs for the first 24hrs post operatively |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
18/09/2025 |
| 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
|
prospective, double-blinded , interventional study comparing the analgesic efficacy of 2 regional analgesia techniques- posterior Quadratus lumborum block( group 2) and subcostal TAP block(group 1) in patients undergoing laparoscopic cholecystectomy under general anaesthesia. This study aims to evaluate the post operative analgesia provided by the 2 blocks by evaluating the Visual Analogue Scale(VAS) score at fixed time intervals(0 , 6 ,12 and 24hours) , the timing of the first rescue analgesia and total 24hour analgesic consumption. a total of 50 patients (25/ group) will be assigned among the two groups and ultrasound guided blocks will be given with 20ml 0.2% Ropivacaine + 4mg Dexamethasone. the study hypothesises that Quadratus lumborum block provides more analgesia than subcostal TAP block as it can extend upto the thoracic paravertebral space or the toracolumbar space. hence the findings from this study can be used to plan post operative analgesia in laparoscopic cholecystectomy patients |