| CTRI Number |
CTRI/2024/02/063371 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Duration of post operative analgesia in patients undergoing cholecystectomy surgery with bupivacaine. |
|
Scientific Title of Study
|
Comparison of the efficacy of ultrasound guided erector spinae plane block versus subcostal transverse abdominis plane block with Bupivacaine 0.25% for post operative analgesia 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 Krishna K |
| Designation |
Associate professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology
Mandya institute of medical sciences
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
Mandya institute of medical sciences
Mandya
KARNATAKA
571401
India |
| Phone |
9448046220 |
| Fax |
|
| Email |
drkris66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna K |
| Designation |
Associate professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya
KARNATAKA
571401
India |
| Phone |
9448046220 |
| Fax |
|
| Email |
drkris66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya Institute of Medical sciences |
|
|
Primary Sponsor
|
| Name |
Dr Krishna K |
| Address |
Associate professor
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bhavyashree G Y |
Assisstant professor
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya |
| Dr Sahana S |
Post graduate student
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sahana S |
Mandya Institute of Medical sciences |
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya
Mandya
KARNATAKA |
9449946766
sahana14m7095@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae block |
Bupivacaine 0.25% 20ml |
| Intervention |
Subcoastal transverse abdominis plane block |
Bupivacaine 0.25% 20ml |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
all patients who are aged between 20 to 60 years of either sex posted for elective laparoscopic cholecystectomy surgery
ASA I and II
BMI less than 30kg per m2
Patients willing to give informed consent |
|
| ExclusionCriteria |
| Details |
Patients allergic to local anaesthetic
Local infections
Uncontrolled diabetes and bleeding diathesis |
|
|
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 analgesia between erector spinae plane block versus subcoastal transverse abdominis plane block |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain VAS score
Total analgesic dose in 24hours
Time to first rescue analgesia |
24 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="0"
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
|
The aim of this study is to compare the effect of erector spinae plane block with transverse abdominis plane block with bupivacaine 0.25% for post operative analgesia. |