| CTRI Number |
CTRI/2024/06/069573 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| 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
|
This study aims to compare 2 facial plane blocks using local anesthestic drug in providing pain free period in patients undergoing abdominal surgeries under general anesthesia |
|
Scientific Title of Study
|
A Study to compare the efficacy and safety of subcostal transverse abdominis plane block versus external oblique intercostal plane block as a part of multimodal analgesia among patients undergoing upper abdominal surgeries
-A single blind , randomised control trial |
| 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 Priyanka D S |
| Designation |
Post graduate student |
| Affiliation |
Bangalore medical college and research institute, Bangalore |
| Address |
3rd floor MPB building, DEPARTMENT OF ANESTHESIOLOGY, Victoria hospital, Bangalore medical college, Bangalore Karnataka -560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9880027712 |
| Fax |
|
| Email |
priyankadrs12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tulsi T |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute, Banglore |
| Address |
3rd floor MPB building, DEPARTMENT OF ANESTHESIOLOGY, Victoria hospital, Bangalore medical college, Bangalore Karnataka -560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9483188870 |
| Fax |
|
| Email |
drtulsikeshav1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tulsi T |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute, Banglore |
| Address |
3rd floor MPB building, DEPARTMENT OF ANESTHESIOLOGY, Victoria hospital, Bangalore medical college, Bangalore Karnataka -560002
KARNATAKA
560002
India |
| Phone |
9483188870 |
| Fax |
|
| Email |
drtulsikeshav1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute, Bangalore Karnataka -560002 |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka D S |
| Address |
3rd floor MPB building, DEPARTMENT OF ANESTHESIOLOGY, Victoria hospital, Bangalore medical college, Bangalore Karnataka -560002 |
| 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 Priyanka D S |
Bangalore medical college and research institute, Bangalore |
3rd floor MPB building, DEPARTMENT OF ANESTHESIOLOGY, Victoria hospital, Bangalore medical college, Bangalore Karnataka -560002
Bangalore
KARNATAKA |
9880027712
priyankadrs12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE |
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 |
External oblique intercostal plane block |
After induction of general anaesthesia, patient in supine position , under asepsis and under ultrasound guidance bilateral external oblique intercostal plane block plane block with inj bupivacaine 0.25% 20 ml each side given after negative aspiration for blood . |
| Comparator Agent |
Subcostal transverse abdominis plane block |
After induction of general anaesthesia, patient in supine position , under asepsis and under ultrasound guidance bilateral subcostal transverse abdominis plane block with inj bupivacaine 0.25% 20 ml each side given after negative aspiration for blood . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patient willing to give informed written consent
2.American society of anesthesiologist grade 1 and 2 , 3.scheduled to undergo elective upper abdominal surgeries under general anesthesia (epigastric herniotomy, gastrectomy,open cholecystectomy, gastric perforation repair) |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to give informed written consent 2. Allergy to local anesthetics
3. Infection at the site of injection 4.coagulopathy.5.prolonged opioid medication 6.chronic liver disease, chronic renal disease and cognitive impairment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Duration of post operative analgesia
2.Time for requirement of first rescue analgesia
3.post operative pain scores(VAS Scores)
4. Total consumption of rescue analgesia in 24 hours |
Immediate postoperative period, 2 hours, 6 hours 12 hours 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic monitoring
|
Immediate postoperative period,1,2,6,12,24 hours after tracheal extubation |
|
|
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 4 |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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="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
|
50 patients of ASA grade 1 and 2 undergoing upper abdominal surgeries under general anaesthesia are randomly allocated into 2 groups. Group S - 25 patients receiving subcostal transverse abdominis plane block Group E- 25 patients receiving External oblique intercostal plane block After induction of general anesthesia, patient in supine position, under asepsis and under ultrasound guidance sono anatomy identified and block given with inj bupivacaine 0.25% 20 ml each side after negative aspiration for blood .after completion of surgery , inhalational agents discontinued, 100 % oxygen given , neuromuscular agents reversed with glyco pyrolate and neostigmine. Extubation done once patient has met extubation criteria is met.. Post operative hemodynamic monitoring , assessment of pain using VAS Scores , first rescue analgesia and total analgesic requirement in 24 hours is assessed.. data analysis done by descriptive statistics. |