| CTRI Number |
CTRI/2024/01/061571 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
We compare Rhomboid intercostal and subserratus plane block with Rhomboid intercostal plane block alone for pain management in breast surgeries |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of Rhomboid intercostal and subserratus plane block with Rhomboid intercostal plane block alone in patients undergoing modified radical mastectomy:A randomized 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.Rehana Aliyar |
| Designation |
Academic junior resident |
| Affiliation |
AIIMS Patna |
| Address |
Room No:13,Department of anaesthesiology,Ground floor AIIMS Patna OPD complex
Patna
BIHAR
801507
India |
| Phone |
9447149893 |
| Fax |
|
| Email |
rehana95123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Poonam Kumari |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
Room No:504, IPD 5th floor OT complex, AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
7992418189 |
| Fax |
|
| Email |
drpoonamk@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Rehana Aliyar |
| Designation |
Academic junior resident |
| Affiliation |
AIIMS Patna |
| Address |
Room No:13,Department of anaesthesiology,Ground floor,AIIMS Patna OPD complex
Patna
BIHAR
801507
India |
| Phone |
9447149893 |
| Fax |
|
| Email |
rehana95123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, All India Institute of Medical Sciences,Patna, Phulwarisharif,Bihar,India pin:801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
Department of anaesthesiology,B Block OT complex, 5th floor IPD |
| 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 |
| DrRehana Aliyar |
All India Institute of Medical Sciences Patna |
Department of anaesthesiology,OT No:04,B block,OT complex,Patna,Bihar
Patna
BIHAR |
9447149893
rehana95123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,AIIMS Patna |
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 |
Rhomboid intercostal and subserratus plane block |
Single dose of 20 ml 0.25% bupivacaine given in rhomboid intercostal plane and subserratus plane block, single time block ,with a duration of 5-10 minutes
|
| Comparator Agent |
Rhomboid intercostal plane block |
Single dose of 20 ml 0.25% bupivacaine given in rhomboid intercostal plane block,given single time at a duration of 5-10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients aged 18 to 70 yearsASA 1 and 2 patients scheduled for Modified Radical Mastectomy Surgery |
|
| ExclusionCriteria |
| Details |
patients aged less than 18 years and more than 70 years
ASA 3 and 4 patients
patients refusing for study
local site infection or lesions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post operative 24 hour opioid consumption |
from the end of surgery to 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the time of first rescue analgesic administration |
from the time of administration of block to the first need of use of analgesic administration |
| to compare intra operative opioid consumption |
from the time of administration of block to the end of the surgery |
| to measure the average pain NRS score at 24 hour post operative period. |
30 minutes, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/01/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Pain following modified radical mastectomy surgeries are common these days.Many blocks have been performing for reducing the incidence of pain and to reduce the opiod consumption .So in this study,we are going to compare the efficacy of rhomboid intercostal and subserratus plane block with rhomboid intercostal plane block alone ,to find out which one gives better analgesia 24 hours following surgery, in terms of opioid consumption, first rescue analgesic administration and average pain NRS score. |