| CTRI Number |
CTRI/2024/05/067573 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Examining pain relief in the post operative period in Breast Surgery patients: A comparative study of Ultrasound Guided Single Level Vs Bi Level Erector Spinae Plane Block |
|
Scientific Title of Study
|
Comparison of Ultrasound Guided Single Level with Bi Level Erector Spinae Plane Block for Post Operative Analgesia in patients undergoing Modified Radical Mastectomy under General Anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEBETSAPHI NONGLAIT |
| Designation |
PG ANAESTHESIA |
| Affiliation |
ATAL BIHARI VAJPAYEE INSTITUTE OF MEDICAL SCIENCES and DR. RAM MANOHAR LOHIA HOSPITAL, NEW DELHI |
| Address |
ROOM NO 512, A BLOCK, NEW DOCTORS HOSTEL, Dr RAM MANOHAR LOHIA HOSPITAL, NEW DELHI, 110001
Central
DELHI
110001
India |
| Phone |
7289865358 |
| Fax |
|
| Email |
mebetsaphi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AKHILESH GUPTA |
| Designation |
Professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital. |
| Address |
Room no 302, Academic Wing, Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital.
Central
DELHI
110001
India |
| Phone |
9810685426 |
| Fax |
|
| Email |
drakhileshgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AKHILESH GUPTA |
| Designation |
Professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital. |
| Address |
Room no 302, Academic wing, Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi.
Central
DELHI
110001
India |
| Phone |
9810685426 |
| Fax |
|
| Email |
drakhileshgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi, India , pin: 110001. |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr Ram Manohar Lohia Hospital |
| Address |
Baba Kharak Singh Marg New Delhi 110001 |
| 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 Mebetsaphi Nonglait |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital. |
Department of Anaesthesia ABVIMS and Dr RML Hospital
Central
DELHI |
7289865358
mebetsaphi@gmail.com |
|
|
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bi Level Erector Spinae Plane Block (Group B) |
Patients posted for Modified Radical Mastectomy will receive Erector Spinae Plane Block for post operative analgesia. Patients will be randomized using sealed envelope technique and will be divided into two groups (S and B). Group B patients will receive Bi Level Erector Spinae Plane Block with 10ml of 0.25% Bupivacaine at level T3 and T5 each. Total duration of intervention will be 20 minutes approximately. Pain intensity will be assessed by Numerical Rating Scale (NRS) at arrival in the recovery room (time 0) and 1,6,12 and 24 hours post operatively. Time for first rescue analgesia will be noted. Adverse effects, if any, will be noted. |
| Comparator Agent |
Single Level Erector Spinae Plane Block (Group S) |
Patients posted for Modified Radical Mastectomy will receive Erector Spinae Plane Block for post operative analgesia. Patients will be randomized using sealed envelope technique and will be divided into two groups (S and B). Group S will receive Single Level Erector Spinae Plane Block with 20ml of 0.25% Bupivacaine at level T4. Total duration of the intervention will be 20 minutes approximately. Pain intensity will be assessed by Numerical Rating Scale (NRS) at arrival in the recovery room (time 0) and 1,6,12 and 24 hours post operatively. Time for first rescue analgesia will be noted. Adverse effects, if any, will be noted. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1) Adult female patients
2) Patients of ASA Grade I and ASA Grade II
3)Patients posted for Modified Radical Mastectomy |
|
| ExclusionCriteria |
| Details |
1) Allergy to Local Anaesthesia
2) Infection at injection site
3) Coagulopathy
4) BMI more than 30kg/m2 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical Rating Scale (NRS) for post operative analgesia |
1) After arrival in the recovery room (Time 0)
2) 1,6, 12 and 24 Hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To note the time for first rescue analgesia
2) To note adverse effects, if any, in both the groups |
1) After arrival in the recovery room (Time 0)
2) 1,6,12 and 24 hours post-operatively |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
01/06/2024 |
| 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="4"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a Randomized Prospective Controlled Study to compare post operative analgesia in 78 patients undergoing Modified Radical Mastectomy. The patients are randomized using sealed envelope technique and they will be divided into group S and group B depending on which envelope they choose. Group S will receive Single Level Erector Spinae Plane Block at Level T4 and group B will receive Bi Level Erector Spinae Plane Block at level T3 and T5. Pain intensity will be assessed using Numerical Rating Scale (NRS) after arrival at the recovery room (time 0) and 1,6,12,24 hours post-operatively. Time for rescue analgesia will be noted. Adverse effects, if any, will be noted in both the groups. |