| CTRI Number |
CTRI/2024/03/063407 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Pecs block type II with Erector spinae plane block in Providing Pain Relief Postoperatively in Patients Undergoing Breast Surgery |
|
Scientific Title of Study
|
Comparison Of Pecs Block Type II with Erector Spinae Block for Post Operative Analgesia in Patients Undergoing Modified Radical Mastectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bonnie Garnette Floster Tariang |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
8377054629 |
| Fax |
|
| Email |
bonnietariang29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharam Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharam Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital |
| 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 Bonnie Garnette Floster Tariang |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care, Main OT complex, Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi
South
DELHI |
8377054629
bonnietariang29@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector Spinae plane (ESP) block for postoperative analgesia |
Patients undergoing modified radical mastectomy under general anaesthesia will be given ultrasound guided ESP block for postoperative analgesia and opioid consumption in a period of 24 hours is noted. |
| Intervention |
PECS BLOCK TYPE II for postoperative analgesia |
Patients undergoing modified radical mastectomy under general anaesthesia will be given ultrasound guided PECS block for postoperative analgesia and opioid consumption in a period of 24 hours is noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anaesthesiologists physical status I and II undergoing Modified Radical Mastectomy |
|
| ExclusionCriteria |
| Details |
1.Body mass index more than 35kg/m2
2.Allergy to intervention drugs(local anaesthetics), coagulopathy and any skin infection at needle puncture site
3.Recent history of receiving opioid drugs
4.Patients with known psychiatric disorder |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the total amount of opioid consumption in post operative period of 24 hours for determining the post operative analgesic efficacy of PECS block and erector spinae plane block in patients who underwent modified radical mastectomy. |
Total amount of opioid required in first 24 hours postoperatively.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time to first requirement of rescue analgesic post operatively.
To assess pain score using Visual Analogue Scale score in the post operative period. |
Time to first rescue analgesic required in first 24 hours post operatively.
Visual Analogue Scale score at 0, 1, 2, 6, 12 and 24 hours in the post operative period. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| 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
|
This study is a randomised comparative study which compares the analgesic efficacy between PECS Block type II and Erector spinae plane block in post operative period in patients who underwent modified radical mastectomy under general anaesthesia. The primary outcome measure will be to compare the total amount of opioid consumption in post operative period of 24 hours for determining the post operative analgesic efficacy of PECS block and erector spinae plane block. The secondary outcomes will be to compare the time to first requirement of rescue analgesic post operatively and to assess pain score using Visual Analogue Scale score at 0, 1, 2, 6, 12 and 24 hours in the post operative period. |