| CTRI Number |
CTRI/2020/06/025660 [Registered on: 05/06/2020] Trial Registered Prospectively |
| Last Modified On: |
27/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate Analgesic Effect of Dexmedetomidine with Ropivacaine in USG Guided Erector Spinae Plane Block for Breast Surgery |
|
Scientific Title of Study
|
To Evaluate Analgesic efficacy of Dexmedetomidine as an adjuvant to Ropivacaine in USG Guided Erector Spinae Plane Block for Modified Radical mastectomy Surgery: A Prospective Randomised, Double blind Clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indira Kumari |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical College and Hospital |
| Address |
Department of Anaesthesiology RNT Medical college and Hospital
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414176760 |
| Fax |
|
| Email |
dr_ikumari@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indira Kumari |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical College and Hospital |
| Address |
Department of Anaesthesiology RNT Medical college and Hospital
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414176760 |
| Fax |
|
| Email |
dr_ikumari@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Boliwal |
| Designation |
Resident |
| Affiliation |
RNT Medical College and Hospital |
| Address |
Department of Anaesthesiology RNT Medical college and Hospital
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9928015710 |
| Fax |
|
| Email |
kboliwal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Maharana Bhopal Government Hospital |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Maharana Bhupal Government Hospital |
| Address |
RNT Medical College and Hospital |
| 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 Krishna Boliwal |
General Surgery Operation Theater Second Floor |
Department of Anaesthesiology Maharana Bhopal Government Hospital RNT Medical College
Udaipur
RAJASTHAN |
9928015710
kboliwal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITALS UDAIPUR |
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 |
| Comparator Agent |
Dexmedetomidine 1 mcg/kg with Ropivacaine 0.375% 20 ml |
Dexmedetomidine 1 mcg/kg with Ropivacaine 0.375% 20 ml will be given by USG Guided Erector Spinae Plane Block at T5 level |
| Intervention |
Erector Spinae Plane Block |
USG guided unilateral Erector spinae Plane Block at T5 level |
| Comparator Agent |
Ropivacaine 0.375% 20 ml
|
Ropivacaine 0.375% 20 ml will be given by USG Guided Erector Spinae Plane Block at T5 level |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA Grade I and II
Posted for Modified Radical Mastectomy surgery |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA Grade III and above
Drug allergy
Obese(BMI >35 kg per sq.m)
Bradycardia
Coagulopathy
Cardiac Conduction Block
Infection at Injection site
patient n beta blocker or antiplatelet
Psychiatric illness
Chronic analgesic Use
|
|
|
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 |
Quality of analgesia
Duration of analgesia
|
24 hour post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intra operative hemodynamic
Adverse effect |
Intra operatively
24 hour post operatively |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/06/2020 |
| 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
|
till date study is not started, No any part of study has been sent for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
i am evaluating analgesic efficacy of Dexmedetomidine as an adjuvant to Ropivacaine in USG Guided ESPB for MRM surgery. kindley considere this trial for CTRI registration. |