| CTRI Number |
CTRI/2025/02/079978 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| 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
|
Comparing two different Regional Anesthesia Techniques for pain relief in patients undergoing minimally invasive colorectal surgeries. |
|
Scientific Title of Study
|
Comparison of ultrasound guided Lateral Quadratus Lumborum block versus Epidural block for post-operative analgesia in minimally invasive colorectal surgery:A prospective randomised controlled comparative 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 |
Nasrin Nisha N |
| Designation |
Post Graduate Resident - MD Anaesthesiology |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
105,Department of Anaesthesiology and Pain Relief, Kidwai Memorial Institute of Oncology,Bangalore.
105, Department of Anaesthesiology,Kidwai Memorial Institute of Oncology, Dr MH, Marigowda Road,Hombegowda Nagar,Bangalore-560029,Karnataka.
Bangalore
KARNATAKA
560029
India |
| Phone |
7358248898 |
| Fax |
|
| Email |
nnasrinnisha01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arathi B H |
| Designation |
Professor and HOD of Anaesthesiology |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
105, Department of Anaesthesiology,Kidwai Memorial Institute of Oncology, Dr MH, Marigowda Road,Hombegowda Nagar,Bangalore-560029,Karnataka.
105, Department of Anaesthesiology and Pain Relief,Kidwai Memorial Institute,Bangalore-560029,Karnataka.
Bangalore
KARNATAKA
560029
India |
| Phone |
9845285207 |
| Fax |
|
| Email |
arathibh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namratha G C |
| Designation |
Assistant Professor in Anesthesiology |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Room No:105, Department of Anaesthesiology and Pain Relief,Kidwai Memorial Institute of Oncology, Dr MH, Marigowda Road,Hombegowda Nagar,Bangalore-560029,Karnataka.
105, Department of Anaesthesiology,Kidwai Memorial Institute of Oncology,Bangalore-560029,Karnataka.
Bangalore
KARNATAKA
560029
India |
| Phone |
7760771417 |
| Fax |
|
| Email |
gc.namratha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kidwai Memorial Institute of Oncology, Dr MH Marigowda Road, Hombegowda Nagar, Bangalore-560029, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Dr Nasrin Nisha N |
| Address |
105,Department of Anaesthesiology, Kidwai Memorial Institute of Oncology, Dr MH Marigowda Road, Hombegowda Nagar, Bangalore-560029, Karnataka,India |
| 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 Nasrin Nisha N |
Kidwai Memorial Institute of Oncology |
Room No 105, Department of Anaesthesiology and Pain Relief, OT complex, Dr MH Marigowda Road, Hombegowda Nagar, Bangalore-560029, Karnataka,
Bangalore
KARNATAKA |
7358248898
nnasrinnisha01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDICAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Epidural block |
Before the surgery, under strict aseptic precautions, 18 G Tuohy epidural needle inserted at the thoracic level of T12-L1 by loss of resistance technique in sitting position.The catheter will be advanced 3 cm cephalad and then Lignocaine 2% with Adrenaline (1:200000) -3ml will be injected as a test dose and catheter will be fixed. After the surgery,
6ml of 0.25% Bupivacaine (15mg) and 4 mg Dexamethasone will be given as single bolus injection in the epidural catheter and the post operative analgesia will be assessed by Visual Analogue Score for 24 hours post surgery. |
| Intervention |
Ultrasound guided lateral Quadratus Lumborum Block |
To the patients undergone minimally invasive colorectal surgeries single dose bilateral ultrasound guided Lateral Quadratus Lumborum Block will be performed under aseptic precautions in supine position by placing the linear ultrasound transducer in transverse orientation at midaxillary line,between the iliac crest and the costal margin to visualize the abdominal wall muscles and the transducer will then slide posteriorly until the posterior aponeurosis of transversus abdominus, internal oblique and the Quadratus Lumborum muscles are identified. Then the needle will be inserted in plane from either anterior or posterior end of the transducer, until the tip pierces the posterior aponeurosis of transversus abdominus muscle, lateral to Quadratus Lumborum muscle.20 ml of 0.25% Bupivacaine (50mg) and 4 mg Dexamethasone will be injected bilaterally once, and the post operative analgesia will be monitored for 24 hours using visual analogue score. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have given consent.
ASA 1 and 2 patients
Body Mass Index 18-40 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patients refusal.
Allergic to local anaesthetics.
Unable to comprehend VAS scale.
With severe cardio pulmonary dysfunction/ coagulopathy/ puncture site infection.
Conversion of minimally invasive colorectal surgery to open surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the USG guided lateral quadratus lumborum block with epidural block for post operative analgesia in patients undergoing minimally invasive colorectal surgery. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time to first request of rescue analgesia in both the groups.
To compare the total requirement of fentanyl (mcg) in 24 hours post surgery in both the groups.
To evaluate the side effects like hypotension and motor weakness in both the groups. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/02/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective randomised controlled study, comparing the ultrasound guided lateral Quadratus Lumborum (QL) Block versus Epidural analgesia (EA) for post operative analgesia in patients undergoing minimally invasive colorectal surgery. In QL group USG guided Lateral Quadratus Lumborum block is given with 20 ml of 0.25% Bupivacaine and 4mg Dexamethasone in supine position bilaterally post surgery. In EA group, epidural catheter is inserted and test dose given prior to surgery and bolus epidural injection with 6 ml of 0.25% Bupivacaine and 4 mg Dexamethasone is given post surgery, adequacy of pain relief will be assessed using VAS scale at 2,4,8,12,16,20 & 24 hours post surgery.The time to first request of rescue analgesia with Fentanyl and its total dose requirement in 24 hours are also noted.The side effects like hypotension and motor weakness are also assessed in both the groups. |