| CTRI Number |
CTRI/2025/07/091905 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational Longitudinal study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Quadratus Lumborum Block with Bupivacaine after Abdominal Surgeries |
|
Scientific Title of Study
|
Comparison of the Effectiveness of Bupivacaine Versus Bupivacaine with Dexamethasone as Adjuvant for Postoperative Analgesia in Ultrasound Guided Quadratus Lumborum Block for Lower abdominal 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 |
Dr Krishna K |
| Designation |
Associate Professor |
| Affiliation |
Mandya Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology MIMS Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9448046220 |
| Fax |
|
| Email |
drkris66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna K |
| Designation |
Associate Professor |
| Affiliation |
Mandya Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology MIMS Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9448046220 |
| Fax |
|
| Email |
drkris66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Sushma |
| Designation |
Post graduate |
| Affiliation |
Mandya Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology MIMS Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
7815805487 |
| Fax |
|
| Email |
ksushmarathod@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya Institute Of Medical Sciences Mandya 571401 |
|
|
Primary Sponsor
|
| Name |
Dr Krishna K |
| Address |
Department of Anaesthesiology Mandya Institute Of Medical Sciences 571401 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr K Sushma |
Department of Anaesthesiology Mandya Institute Of Medical Sciences 571401 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna K |
Mandya Institute Of Medical Sciences |
Department of ANESTHESIOLOGY
1st floor 3rd cross guthal road maruthi nagar mandya
Mandya
KARNATAKA |
9888046220
drkris66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, MANDYA INSTITUTE OF MEDICAL SCIENCES |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BMI less than 30kg/m2
ASA I and II Undergoing lower abdominal surgeries |
|
| ExclusionCriteria |
| Details |
Patients with coagulopathy, local infection at needle insertion site
Duration of surgery more than 2 hours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesia between bupivacaine 0.25% versus bupivacaine 0.25% with dexamethasone 8mg |
30hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative Complications |
24hours |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2025 |
| 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="1"
Months="0"
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
|
This study is designed to compare the duration of postoperative analgesia in patients undergoing lower abdominal surgeries using bupivacaine alone and bupivacaine with dexamethasone |