| CTRI Number |
CTRI/2024/07/069859 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing post operation pain relief given by the different types of two blocks used for patients undergoing abdominal surgery |
|
Scientific Title of Study
|
Comparison of Modified Thoraco Abdominal nerve block through Perichondrial Approach with External Oblique Intercostal Plane Block for postoperative analgesia in patients undergoing 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 Tamilarasan V |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung hospital,New Delhi
South
DELHI
110029
India |
| Phone |
7639028678 |
| Fax |
|
| Email |
tamilvelu1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Guria |
| Designation |
Consultant and Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung hospital,New Delhi
South
DELHI
110029
India |
| Phone |
9871350066 |
| Fax |
|
| Email |
drsushilguria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushil Guria |
| Designation |
Consultant and Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung hospital,New Delhi
DELHI
110029
India |
| Phone |
9871350066 |
| Fax |
|
| Email |
drsushilguria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung
hospital, Ansari Nagar
New Delhi -110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi |
| Type of Sponsor |
Government 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 |
| Dr Tamilarasan V |
Vardhman Mahavir Medical College and Safdarjung hospital |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung hospital,New Delhi
South
DELHI |
7639028678
tamilvelu1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
External Oblique Intercostal Plane Block.Total duration of study is 18 months |
0.25% bupivacaine will be given for postoperative analgesia in patients undergoing laparoscopic cholecystectomy using External Oblique Intercostal Plane Block approach.Total duration of study is 18 months |
| Intervention |
Modified Thoraco Abdominal nerve block through Perichondrial Approach.Total duration of study is 18 months |
0.25% bupivacaine will be given for postoperative analgesia in patients undergoing laparoscopic cholecystectomy using Modified Thoraco Abdominal nerve block through Perichondrial Approach . Total duration of study is 18months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists physical status grade I and II scheduled for laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Infecction at the site of block, pregnancy, Allergic to local Anaesthetics, Age less than 18 yrs |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare modified thoraco abdominal nerve block through Perichondrial Approach with External Oblique Intercostal Plane Block for analgesia determined by total Tramadol requirement |
During first 24hours of post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Rating Scale |
1,2,6,12,24 hours |
| Total fentanyl requirement |
During intra operative period |
| Time to first rescue analgesia demand |
In post operative period |
| Quality of recovery score |
In post operative 24 hrs |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/07/2024 |
| 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="1"
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
|
This study is undertaken to compare the modified Thoraco Abdominal nerve block through Perichondrial approach with External Oblique Intercostal Plane Block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy.Primarily determined by total tramadol requirement during first 24hours of post operative period.Secondarily Numeric Rating Scale pain scores,total fentanyl requirement during intraoperative period,time to first rescue analgesia demand and Quality of Recovery score -15 will be assessed. |