| CTRI Number |
CTRI/2025/05/087897 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two anesthetic blocks namely erector spinae block and modified pectoral nerve block for post surgical analgesia in patients undergoing breast cancer surgeries under general anesthesia. |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of Erector Spinae Plane Block and Modified
Pectoral Nerve Block for Postoperative analgesia in patients undergoing breast malignancy
surgeries under General anesthesia: A Randomised Controlled 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 Akash Parashram Garkal |
| Designation |
Junior Resident, Department of Anaesthesiology |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences, Sevagram |
| Address |
Department of Anaesthesiology, Main operation theatre complex, Mahatma Gandhi Institute of Medical Sciences Sevagram, Wardha, Maharashtra, India
Wardha
MAHARASHTRA
442102
India |
| Phone |
9850168710 |
| Fax |
|
| Email |
akashgarkal@mgims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhiraj Bhandari |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences, Sevagram |
| Address |
Department of Anaesthesiology, Main operation theatre complex, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra, India
Wardha
MAHARASHTRA
442102
India |
| Phone |
9970195086 |
| Fax |
|
| Email |
dhirajbhandari@mgims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akash Parashram Garkal |
| Designation |
Junior Resident, Department of Anaesthesiology |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences, Sevagram |
| Address |
Department of Anaesthesiology, Main operation theatre complex, Mahatma Gandhi Institute of Medical Sciences, Sewagram, Wardha, Maharashtra, India
Wardha
MAHARASHTRA
442102
India |
| Phone |
9850168710 |
| Fax |
|
| Email |
akashgarkal@mgims.ac.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Institute of Medical Sciences Sevagram, Wardha 442102 Maharashtra, INDIA |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Institute of Medical Sciences Sevagram |
| Address |
Department of Anaesthesiology, Main operation theatre complex, Mahatma Gandhi Institute of Medical Sciences, Sewagram, Wardha, Maharashtra, India. 442102 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Akash Parashram Garkal |
Mahatma Gandhi Institute of Medical Sciences, Sevagram |
Department of Anaesthesiology, Main operation theatre complex, Mahatma Gandhi Institute of Medical Sciences, Sewagram, Wardha, Maharashtra, India. 442102
Wardha
MAHARASHTRA |
9850168710
akashgarkal@mgims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MGIMS SEVAGRAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector spinae plane block |
After general anaesthesia to patient undergoing breast surgery, patient in this group will receive ultrasound guided erector spinae plane block using 10cc of 0.25% Injection BUPIVACAINE. Post operatively analgesic Injection TRAMADOL requirement for 24 hours will be calculated. |
| Intervention |
Modified Pectoral Nerve Block |
After giving general anaesthesia to patient undergoing breast surgery , patient in this group will receive an ultrasound guided pectoral nerve block using 10cc of 0.25% Injection BUPIVACAINE . Post operatively analgesic Injection TRAMADOL requirement for 24 hours will be calculated. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1) American society of Anesthesiology 1 and 2
2) patient more than 18 year
3)weight more than 35 kg |
|
| ExclusionCriteria |
| Details |
1) The patient refused to undergo the study procedure.
2) The patient has a history of allergies to drugs or drug components used in the study. 3) The patient has a history of neurological deficits.
4) Patients with opioid dependence or addiction are excluded.
5) Patients with American Society of Anesthesiologists physical status classification III or IV are excluded.
6) Patients who took analgesics within 24 hours prior to induction are excluded. 7) Patients with infections at the site of injection are excluded.
8) Patients with inherited or acquired coagulopathies are excluded.
9) Patients on systemic anticoagulation therapy are excluded.
10) Patients with a BMI over 40 are excluded.
11) Patients with psychiatric disorders are excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare Total TRAMADOL consumption in the first 24 hours between two groups of patients who are undergoing breast malignancy surgeries under general anesthesia (GA) with either Erector Spinae Plane block or Modified Pectoral nerve block.
|
AFTER 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To calculate VAS score
To check additional analgesia requirement |
To check any side effects of procedure |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
09/06/2025 |
| 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="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 to evaluate efficacy and safety profile between Erector Spinae Plane block and Modified Pectoral nerve block in patients undergoing breast malignancy surgeries under general anesthesia (GA). During surgery first patient will undergo general anaesthesia after that assigned ultrasound guided block will be given to patient ,Efficacy will be calculated by consumption analgesic TRAMADOL in first 24 hours after block along with post op VAS score, additional analgesic requirement , hemodynamic changes after block
|