| CTRI Number |
CTRI/2024/04/066198 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Erector Spinae Plane Block with Modified Pectoral Nerve Block in Breast
Cancer Surgery for post operative pain |
|
Scientific Title of Study
|
Comparative evaluation of ultrasound guided Erector Spinae Plane Block versus Modified Pectoral Nerve Block for post operative analgesia and stress response 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 |
Dr Avnika Laller |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room no.415 3rd Floor BL Taneja Block Department of Anesthesiology Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9873130277 |
| Fax |
|
| Email |
avnika1june@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalit Gupta |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room no.415 3rd Floor BL Taneja Block Department of Anesthesiology Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9868092739 |
| Fax |
|
| Email |
lalit.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avnika Laller |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room no.415 3rd Floor BL Taneja Block Department of Anesthesiology Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9873130277 |
| Fax |
|
| Email |
avnika1june@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hsospital,JLN 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 Avnika Laller |
Lok Nayak Hospital |
Department of Anesthesiology and intensive care, BL Taneja block, Maulana Azad medical college and associated Lok Nayak Hospital, JLN Marg
Central
DELHI |
9873130277
avnika1june@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
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 |
Erector Spinae Plane Block |
The Erector Spinae Plane Block will be performed after induction with the patient in lateral decubitus position by an experienced anesthesiologist.The USG probe will be placed on T4 transverse process on the operative side.A 100mm,22-gauge block needle will be directed towards the lateral margin of the transverse process.A pre-prepared solution of 20ml of 0.2% ropivacaine(max. of 2mg/kg) with 0.5mcg/kg dexmedetomidine will then be administered deep to the Erector Spinae Muscle Plane.After completion Of Erector Spinae Plane Block,(approximate duration of block administration procedure will be 10 minutes)surgery will commence |
| Comparator Agent |
Modified Pectoral Nerve Block |
The Modified Pectoral Nerve Block will be performed after induction with the patient in supine position with ipsilateral arm abducted to 90 degrees by an experienced anesthesiologist. The USG probe will be placed below lateral third of clavicle on operative side.After identification of axillary vessels probe will be moved inferolaterally until the pectoralis major,pectoralis minor and serratus anterior muscles are seen in one plane. A 22-gauge,100 mm block needle will be advanced towards the interfascial plane between pectoralis major and pectoralis minor and a pre-prepared solution of 10ml of 0.2% ropivacaine with 0.5mcg/kg dexmedetomidine will be injected. Then probe will be moved towards axilla till serratus anterior muscle will be identified above third and fourth ribs and a pre-prepared solution of 20ml of 0.2% ropivacaine with 0.5mcg/kg dexmedetomidine will be injected above the serratus anterior muscle. After completion of Modified Pectoral Nerve Block(approximate duration of block administration procedure will be 10 minutes) surgery will commence. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.18 to 65 years of age
2.American Society of Anesthesiologists Physical Status I or II |
|
| ExclusionCriteria |
| Details |
1.History of Neuropsychiatric Disorders
2.Infection at local site
3.Coagulopathies and Thrombocytopenia(platelet count less than 1 lacs)
4.BMI more than 30kg/m2
5.On chronic treatment with opioids
6.Pregnancy
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to request for 1st supplemental analgesic requirement post-operatively |
In postoperative period at 0 minutes,30 minutes,2 hours,4 hours,6 hours,12 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hemodynamic changes(Heart Rate and Mean Arterial Pressure)will be monitored and recorded before induction(baseline),after induction, post block, at skin incision and for every 15 minutes intra-operatively
2.Post-operative NRS score till 24 hours
3.Total amount of analgesic consumption in 24 hours postoperatively
4.Neutrophil Lymphocyte Ratio,Serum Cortisol and Interleukin-6 blood levels before induction and 6 hours post surgery
5.Patient satisfaction score at 24 hours
6.Block related complications, if any |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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="0"
Days="0" |
|
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
|
We are comparing Erector Spinae Plane Block with Modified Pectoral Nerve Block for post operative analgesia and stress response in patients posted for Modified Radical Mastectomy in Lok Nayak Hospital Delhi. A total of 42 patients with 21 patients in each group will be enrolled for the study. Patients will be explained about the study and written informed consent will be taken. A Preoperative blood sample (total of 6ml) will be taken for analyzing serum cortisol, Neutrophil Lymphocyte ratio and Interleukin-6 blood levels. We will be using standard general anesthesia for induction of patients following which USG guided block site will be identified and local anesthetic drug will be administered. Patients will be followed up post operatively for 24 hours during which numerical rating scale for pain, time for first supplemental analgesia and total amount of analgesic consumption will be determined. Another blood sample(total of 6ml) will be taken 6 hours post surgery for analyzing serum cortisol, Neutrophil Lymphocyte ratio and Interleukin-6 blood levels. Overall patient satisfaction score will also be assessed. |