| CTRI Number |
CTRI/2023/06/054103 [Registered on: 19/06/2023] Trial Registered Prospectively |
| Last Modified On: |
18/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EXTERNAL OBLIQUE INTERCOSTAL BLOCK VS SUBCOSTAL TAP BLOCK COMPARISON FOR PORT SITES PAIN IN LAP CHOLECYSTECTOMY |
|
Scientific Title of Study
|
COMPARISON OF EXTERNAL OBLIQUE INTERCOSTAL BLOCK VS SUBCOSTAL TAP BLOCK FOR RIGHT UPPER QUADRANT PARIETAL PAIN IN LAP CHOLECYSTECTOMY- A PROSPECTIVE RANDOMISED DOUBLE BLIND STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR CHANDAN KUMAR SHARMA |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
AMRI HOSPITAL, BBSR UNIT |
| Address |
AMRI HOSPITAL, BBSR UNIT, ANESTHESIA DEPARTMENT
Khordha
ORISSA
751019
India |
| Phone |
7873388933 |
| Fax |
|
| Email |
SCHANDAN914@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHANDRASEKHAR PRADHAN |
| Designation |
CONSULTANT |
| Affiliation |
AMRI HOSPITAL , BBSR UNIT |
| Address |
AMRI HOSPITAL, NEAR JAYDEV VATIKA PARK , KHANDAGIRI, BBSR
Khordha
ORISSA
751019
India |
| Phone |
8763584087 |
| Fax |
|
| Email |
DRPAPU@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR CHANDRASEKHAR PRADHAN |
| Designation |
CONSULTANT |
| Affiliation |
AMRI HOSPITAL , BBSR UNIT |
| Address |
AMRI HOSPITAL, NEAR JAYDEV VATIKA PARK , KHANDAGIRI, BBSR
Khordha
ORISSA
751019
India |
| Phone |
8763584087 |
| Fax |
|
| Email |
DRPAPU@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AMRI HOSPITAL, BBSR UNIT |
| Address |
PLOT NO-1, NEAR JAYDEV VATIKA , KHANDAGIRI, BBSR |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 CHANDAN KUMAR SHARMA |
AMRI HOSPITAL BBSR UNIT |
ANAESTHESIA DEPARTMENT, 1ST FLOOR
Khordha
ORISSA |
7873388933
SCHANDAN914@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, AMRI HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EXTERNAL OBLIQUE INTERCOSTAL BLOCK |
UNDER USG GUIDANCE EXTERNAL OBLIQUE INTERCOASTAL BLOCK GIVEN.
TOTAL DURATION 30MINS |
| Comparator Agent |
SUBCOSTAL TAP BLOCK |
UNDER USG GUIDANCE SUBCOSTAL TAP BLOCK GIVEN.
TOTAL DURATION 30MINS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE- I AND II |
|
| ExclusionCriteria |
| Details |
REFUSAL OF THE PATIENT
ASA GRADE -III OR ABOVE
LOCAL SITE INFECTION
DRUG ALLERGY |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VISUAL ANALOG SCALE FOR PAIN ASSESSMENT |
AT- 1HOUR, 4HOUR,8HOUR,16HOUR,24HOUR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| INTRAOPERATIVE VITALS |
AT BASELINE OR 0HOUR |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
26/06/2023 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
BACKGROUND- POST OPERATIVE PAIN IS A MAJOR CONCERN FOR PATIENTS AS IT CAN VARRY FROM VERY SEVERE DEGREE TO MILD PAIN.
PRIMARY PURPOSE- TO COMPARE THE EFFICAY OF EXTERNAL OBLIQUE INTERCOSTAL BLOCK AND SUBCOSTAL TAP BLOCK FOR RIGHT UPPER QUADRANT PAIN IN PATIENTS UNDERGOING LAP CHOLECYSTECTOMY PROCEDURE, SO THAT WE CAN ADOPT THE BEST METHOD FOR PAIN MANGEMENT IN PATIENTS. THIS CAN IMPROVE THE QUALITY OF PATIENT CARE IN FUTURE CASES. |