| CTRI Number |
CTRI/2024/10/075350 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing benifits of adding Dexamathasone versus Dexmeditomidine with Ropivacaine for pain control after breast removal surgeries |
|
Scientific Title of Study
|
Dexamethasone versus Dexmeditomidine as an adjunct to Ropivacaine in Serratus Anterior Plane Block for patients undergoing Modified Radical Mastectomy - A Prospective Randomized Clinical study |
| 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 Akshaya Sreekumar |
| Designation |
Junior resident |
| Affiliation |
All India Institute Of Medical Sciences,Bhopal |
| Address |
Department of Anaesthesiology and Critical Care , AIIMS Campus, Saket Nagar, Bhopal , Madhya Pradesh , 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7994704878 |
| Fax |
|
| Email |
akshaya51297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences ,Bhopal |
| Address |
Department of Anaesthesiology and Critical Care, AIIMS Campus ,Saket Nagar, Bhopal , Madhya Pradesh , 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9471300943 |
| Fax |
|
| Email |
harishcmckol@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences ,Bhopal |
| Address |
Department of Anaesthesiology and Critical Care, AIIMS Campus ,Saket Nagar, Bhopal , Madhya Pradesh , 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9471300943 |
| Fax |
|
| Email |
harishcmckol@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS BHOPAL , non funded |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Anaesthesiology and Critical Care , Saket Nagar , AIIMS BHOPAL ,Madhyapradesh-462020 |
| 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 Akshaya Sreekumar |
AIIMS Bhopal |
Department Of Anaesthesiology and Critical Care ,
Department Of General Surgery & Department Of Surgical Oncology,
AIIMS Campus , Saket Nagar , Bhopal ,Madhya Pradesh , India
Bhopal
MADHYA PRADESH |
7994704878
akshaya51297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bhopal, Institutional Ethics committee -Student Research (IHEC -SR) |
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 |
Dexamethasone as an adjunct to Ropivacaine in Serratus Anterior Plane Block for patients undergoing Modified Radical Mastectomy |
Group A - Serratus Anterior Plane Block with 0.375% Ropivacaine + 2ml (8mg )Dexamethasone (total volume + 0.4 ml/kg)-along the midaxillary line between Serratus Anterior muscle and Latissimus Dorsi Muscle
|
| Comparator Agent |
Dexmeditomidine as an an adjunct to Ropivacaine in Serratus Anterior Plane Block for patients undergoing Modified Radical Mastectomy |
Group B- Serratus Anterior Plane Block with 0.375% Ropivacaine + 1mcg/kg Dexmedetomidine (total volume -0.4ml/kg) -along midaxillary line between Serratus Anterior muscle and Latissimus Dorsi muscle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Breast carcinoma patients undergoing Modified Radical Mastectomy under general Anaesthesia
ASA status 1 &2
Patients who consented to the study |
|
| ExclusionCriteria |
| Details |
Patients who did not consent
Preexisting bleeding disorders
Coagulation disorders
Morbid obesity
Local inflammation
Study drug allergy
Patient with severe chest wall deformity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first rescue analgesia in minutes( defined as time from arrival in the postoperative recovery room to administration to first rescue analgesia ) |
assessment after arrival in the postoperative recovery room and at 1,2,6,12,24 hrs after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.VAS pain score at 1,2,6,12 and 24 hours at rest (supine position ) and during activity (and on 90 degrees abduction of arm ipsilateral to the side of surgery )
2. Total perioperative analgesic consumption (intraoperative fentanyl consumption + diclofenac and tramadol consumption post operatively
3. Monitoring of hemodynamic parameters |
1. VAS pain scores at 1,2,6,12 and 24 hours at rest (supine position ) and during activity (defined as changing position supine to sitting
2.24 hours postoperatively
3. 24 hours postoperatively |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="6"
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
|
Patients undergoing Modified Radical Mastectomy surgeries usually have to go through severe pain postoperatively. Fascial plane blocks are emerging techniques in perioperative pain management. Serratus Anterior Plane block is one such block used in breast surgeries. Dexamethasone and Dexmedetomidine is added as an adjuvant to ropivacaine in this study because they have been reported to increase the efficacy of blockade. This study aims to compare the efficacy of combining Dexamethasone to 0.375% Ropivacaine and Dexmedetomidine to 0.375% Ropivacaine in ultrasound guided Serratus Anterior Plane Block for patients undergoing Modified Radical Mastectomy. Written informed consent will be taken and a thorough preanesthetic evaluation will be done to ensure adherence to inclusion and exclusion criteria. A standard general anesthesia technique will be followed in all patients, After positioning of the patient, under strict aseptic precautions SAPB will be performed under ultrasound guided technique.Further efficacy of the block administered will be assessed with primary and secondary outcomes. |