| CTRI Number |
CTRI/2025/05/087163 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on the Use of Two Different Anaesthetic Combinations with a Pain Reliever to Improve Pain Control During and After Breast Cancer Surgeries Using Ultrasound Guidance |
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Scientific Title of Study
|
A CROSS SECTIONAL COMPARATIVE STUDY TO EVALUATE THE EFFECT OF 0.125 PERCENT ROPIVACAINE WITH DEXMEDETOMIDINE 20 MCG AND 0.125 PERCENT BUPIVACAINE WITH DEXMEDETOMIDINE 20 MCG IN ULTRASOUND GUIDED SERRATUS ANTERIOR PLANE BLOCK IN BREAST SURGERIES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PONRAJ K |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Mahatma Gandhi Memorial Medical college and Hospital |
| Address |
Department of Anaesthesiology,Mahatma Gandhi Memorial medical college and Hospital & M.Y. Hospital, indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9941711126 |
| Fax |
|
| Email |
ponrajkrishnan@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Manish Banjare |
| Designation |
Professor and Head |
| Affiliation |
Mahatma Gandhi Memorial Medical college and Hospital |
| Address |
Department of Anaesthesiology,Mahatma Gandhi Memorial Medical College & M.Y Hospital,Indore.
Indore
MADHYA PRADESH
452001
India |
| Phone |
9826144784 |
| Fax |
|
| Email |
manish_banjare@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.PONRAJ K |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Mahatma Gandhi Memorial Medical college and Hospital |
| Address |
Department of Anaesthesiology,mahatma gandhi memorial medical college and hospital & M.Y. Hospital,Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9941711126 |
| Fax |
|
| Email |
ponrajkrishnan@outlook.com |
|
|
Source of Monetary or Material Support
|
| MAHATMA GANDHI MEMORIAL MEDICAL COLLEGE AND HOSPITAL, AND MAHARAJ YASHWANTRAO HOSPITAL.A B ROAD, INDORE,MADHYA PRADESH,INDIA,452001 |
|
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Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRPONRAJ K |
Maharaj YashwantRoa Hospital |
Department of Anaesthesiology,Mahatma Gandhi Memorial Medical College and Hospotal,A B Road ,Indore
Indore
MADHYA PRADESH |
9941711126
ponrajkrishnan@outlook.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS AND SCIENTIFIC REVIEW COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SERRATUS ANTERIOR PLANE BLOCK |
The block is performed with drug 0.125% ROPIVACAINE WITH DEXMEDETOMIDINE 20 MCG. Total volume of the drug taken is 30 ml . So, 30 ml of drug contains 37.5 mg of Ropivacaine along with dexmeditomedine 20 micrograms.The block is performed only once before starting the surgical incision and may take anywhere between 5 to 10 minutes to administer the block. |
| Comparator Agent |
SERRATUS ANTERIOR PLANE BLOCK |
The block is performed with drugs 0.125% BUPIVACAINE WITH DEXMEDETOMIDINE 20 MCG.The block is performed with drug 0.125% BUPIVACAINE WITH DEXMEDETOMIDINE 20 MCG. Total volume of the drug taken is 30 ml . So, 30 ml of drug contains 37.5 mg of Bupivacaine along with dexmeditomedine 20 micrograms.The block is performed only once before starting the surgical incision and may take anywhere between 5 to 10 minutes to administer the block. |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent
Age between 18-70 years .
American society of anesthesiology(ASA) physical status score of I, II and III
Unilateral breast surgery
|
|
| ExclusionCriteria |
| Details |
Patient with known allergy to drugs used in the study
Bleeding diathesis
Skin pathology at the injection site
Patient with known psychiatric illness
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of ultrasound guided serratus anterior plane block for patients undergoing breast surgeries using Dexmedetomidine 20 mcg in Ropivacaine 0.125% or Bupivacaine 0.125% intraoperative based on hemodynamic changes and post operative analgesia requirement based on NRS score
|
AFTER THE BLOCK,Intraoperative monitoring will begin at induction, followed by checks after LMA insertion, at incision, and then at 5, 10 minutes, and every 30 minutes until the end of surgery. Postoperative monitoring will include checks immediately after surgery, at 10 minutes, 1 hour, and then every 2 hours until the first rescue analgesia that is at NRS SCORE 5 is given.At this point assessment will end. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To compare & evaluate time of first rescue analgesia on the basis of NRS score
|
Postoperative monitoring will include checks immediately after surgery, at 10 minutes, 1 hour, & then every 2 hours until the first rescue analgesia is given which is given at NRS score more than 5.At this point assessment will end. |
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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" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
30/05/2025 |
| 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="0"
Months="4"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
60 ASA(American
society of anesthesiogists) grade I ,II and III patients planned for elective breast surgery,fulfilling the inclusion criteria will be included in the study.
A day before surgery all patients with PAC (pre anaesthetic check-up) done will be reassessed and will be explained the anesthetic procedure.
Patients will be explained about the procedure and due risks involved in their own local language and informed consent for the same will be taken.
Local sensitivity testing will be done for patients to rule out hypersensitivity reactions to drugs used.
Patient will be kept NBM (nil by mouth) for 6 hours before surgery.
Patient will be premedicated with inj.Glycopyrollate 0.2 mg + inj.Midazolam 1mg. and preoxygenated with 100% Oxygen
Patient will be induced with Inj. Fentanyl 2 mcg/kg + Inj. Propofol 2 mg/kg and patients airway will be secured with laryngeal mask airway (LMA) of appropriate size .
For maintenance of anesthesia , inj.Propofol infusion 50-100 mcg/kg/min. + inhalational agent isoflurane will be given.
After securing airway, block will be given using either Ropivacaine 0.125 % with Dexmedetomidine 20 mcg and Bupivacaine 0.125% with Dexmedetomidine 20 mcg with 30 ml of drug volume in each group in accordance with grouping of cases.
In SAP block —> needle is inserted in plane from medial to lateral direction in 4th rib in mid axillary line—> deposit Local anesthesia in plane between pectoralis major and
serratus anterior muscle—> lateral cutaneous branches of intercostal nerves are blocked(5)
In serratus anterior plane block , injection is given superficial between the latissimus dorsi and serratus anterior muscles at the level of the fifth rib on the midaxillary line which blocks the
lateral cutaneous branch of the intercostal nerve and the long thoracic nerve .
The block is performed with the help of a high frequency ( 6 to 13 MHz) linear transducer probe which will allow detailed visualization of superficial structures.
If the effect of serratus anterior plane block is not appropriate during intraoperative time , which will be assessed by change in hemodynamic parameters with 20% increase from baseline being considered as significant , then additional analgesia (inj.Fentanyl 1-2 mcg/kg) will be given and such cases will be excluded from the study .
Intraoperative monitoring will be done starting from incision time and then at appropriate incremental intervals till end of surgery
Postoperative hemodynamic changes will be noted at appropriate incremental intervals till first rescue analgesia is given.
Rescue analgesia will be given with inj.Paracetamol 1 g IV stat when NRS score > 5 postoperatively.
Postoperative adverse effects if any will be noted and managed accordingly.
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