| CTRI Number |
CTRI/2024/08/072663 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of ultrasound guided Erector spinae plane block and Serratus anterior plane block on the immune system response in patients undergoing breast cancer surgery |
|
Scientific Title of Study
|
Effect of ultrasound guided Erector spinae plane block and Serratus anterior plane block on inflammatory response 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 |
Sandeep J |
| Designation |
Post Graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology, 3rd floor, B L Taneja block, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
8610597896 |
| Fax |
|
| Email |
sandeep1998.j@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Prasad |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology, 3rd floor, B L Taneja block, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
01123238058 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelam Prasad |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology, 3rd floor, B L Taneja block, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
01123238058 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi 110 002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Associated Lok Nayak Hospital |
| Address |
No 2, Bahadur Shah Zafar Marg, New Delhi 110002 |
| 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 Sandeep J |
Lok Nayak Hospital, Maulana Azad Medical College |
Room 305, 3rd floor, BL Taneja Block, Department of Anaesthesiology and Intensive Care, Bahadur Shah Zafar Marg
Central
DELHI |
8610597896
sandeep1998.j@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: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane Block |
After induction of general anaesthesia, ultrasound guided Erector spinae plane block at T4-T6 vertebral level will be administered with 20ml 0.5% Ropivacaine with dexmedetomidine 0.5 mcg/kg as adjuvant |
| Intervention |
Serratus Anterior Plane Block |
After induction of general anaesthesia, ultrasound guided Serratus anterior plane block will be administered with 20ml 0.5% Ropivacaine with dexmedetomidine 0.5 mcg/kg as adjuvant |
| Comparator Agent |
Serum Interleukin-6 and Interleukin-10 level |
Serum IL-6 and IL-10 levels will be measured at baseline and 24 hours postoperatively using ELISA kit |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 1, 2, 3 patients |
|
| ExclusionCriteria |
| Details |
1. Bleeding diathesis
2. Local skin infection at the site of block
3. Allergy to local anaesthetics or adjuvants |
|
|
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 |
1. Serum IL-6 concentration in both the groups
2. Serum IL-10 concentration in both the groups |
Baseline and 24 hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum cortisol concentrations in both the groups |
Baseline and 24hrs postoperatively |
| Total consumption of intravenous Fentanyl in both the groups |
During the duration of the surgery |
| Time at which the first rescue analgesia is requested by the patient postoperatively as assessed by the NRS pain score in both the groups |
2hrs, 6hrs, 12 hrs and 24hrs postoperatively |
| Total amount of opioid consumption within 24 hours postoperatively in both the groups |
24 hrs postoperatively |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="0"
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
|
We are comparing the effect of ultrasound guided Erector spinae plane block and Serratus anterior plane block on inflammatory response in patients undergoing modified radical mastectomy under general anaesthesia. The primary objective of the study is to compare the effect of Serratus Anterior plane block and Erector spinae plane block on serum IL-6 and IL-10 levels in patients undergoing Modified Radical Mastectomy under general anaesthesia, taking a sample size of 50 patients for the study. |