| CTRI Number |
CTRI/2021/01/030208 [Registered on: 04/01/2021] Trial Registered Prospectively |
| Last Modified On: |
30/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of blocks for post operative pain management in patients undergoing laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Comparative study of postoperative pain management with erector spinae(ESP) block versus oblique subcostal transverse abdominis plane (OSTAP) block in patients undergoing elective laparoscopic cholecystectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VADDAMANU MOUNIKA |
| Designation |
POST GRADUATE TRAINEE 1st YEAR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,PBMH, KIMS, KIIT UNIVERSITY, PATIA , KHORDA BHUBANESHWAR.
Khordha
ORISSA
751024
India |
| Phone |
8317608900 |
| Fax |
|
| Email |
2087028@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LINGARAJ SAHU |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, PBMH,KIMS,KIIT UNIVERSITY, PATIA KHORDA BHUBANESHWAR.
Khordha
ORISSA
751024
India |
| Phone |
8280166501 |
| Fax |
|
| Email |
lingaraj.sahu@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
VADDAMANU MOUNIKA |
| Designation |
POST GRADUATE TRAINEE 1st YEAR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,PBMH, KIMS, KIIT UNIVERSITY, PATIA , KHORDA BHUBANESHWAR.
Khordha
ORISSA
751024
India |
| Phone |
8317608900 |
| Fax |
|
| Email |
2087028@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| KALINGA INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
VADDAMANU MOUNIKA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,PBMH,KIMS, KIIT UNIVERSITY, BHUBANESWAR,ODISHA. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| VADDAMANU MOUNIKA |
PBMH, KIMS |
DEPARTMENT OF ANAESTHESIOLOGY,PBMH, KIMS,KIIT UNIVERSITY, PATIA, KHORDA, BHUBANESWAR-751024, ORISSA.
Khordha
ORISSA |
8317608900
2087028@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ERECTOR SPINAE BLOCK AND OBLIQUE SUBCOSTAL TRANSVERSE ABDOMINIS PLANE BLOCK. |
TWO BLOCKS WILL BE COMPARED (USING 20ML OF 0.2% ROPIVACAINE AND 4MG OF DEXAMETHASONE BILATERALLY) FOR POSTOPERATIVE PAIN MANAGEMENT |
| Intervention |
ERECTOR SPINAE BLOCK AND OBLIQUE SUBCOSTAL TRANSVERSE ABDOMINIS PLANE BLOCK. |
TWO BLOCKS WILL BE COMPARED (USING 20ML OF 0.2% ROPIVACAINE AND 4MG OF DEXAMETHASONE BILATERALLY) FOR POSTOPERATIVE PAIN MANAGEMENT IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA-PS I and II patients posted for elective laparoscopic cholecystectomy. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Obese patients(BMI>30kg/m2).
Allergy to local anaesthetcis.
Infection at the site of block.
Coagulation disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative analgesic requirement.
1st analgesic requirement. |
1.5 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number and total analgesic requirement.
Intraoperative analgesic requirement.
patient satisfaction. |
1.5 years. |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/01/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ultra sounded guided peripheral nerve blocks is increasing in popularity for postoperative pain management because they cause less interference with the physiology of the body and decreases the use of opioids. In this study two blocks are compared in patients undergoing elective laparoscopic cholecystectomy. One group of patients will be undergoing erector spinae block and other group will be undergoing oblique subcostal transverse abdominis plane block preoperatively. Both the groups will be compared in terms of analgesic efficacy, duration of analgesia and 1st rescue analgesic requirement. |