| CTRI Number |
CTRI/2022/09/045531 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
09/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of a drug (inj Clonidine) with Ropivacaine in a block for control of pain in breast surgery |
|
Scientific Title of Study
|
"Comparison of analgesic effect of Clonidine as adjuvant with 0.35% concentration of Ropivacaine in USG guided thoracic Paravertebral block in modified radical Mastectomy: A prospective randomized double blind Study" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lalit Kumar Raiger |
| Designation |
Senior professor |
| Affiliation |
RNT Medical College, Udaipur |
| Address |
Department of Anaesthesiology, RNT Medical College, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414352823 |
| Fax |
|
| Email |
drlalitkumar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lalit Kumar Raiger |
| Designation |
Senior professor |
| Affiliation |
RNT Medical College, Udaipur |
| Address |
Department of Anaesthesiology ,RNT Medical College, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414352823 |
| Fax |
|
| Email |
drlalitkumar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit kumar mittal |
| Designation |
junior resident doctor |
| Affiliation |
RNT Medical College, Udaipur |
| Address |
Department of Anaesthesiology ,RNT Medical College, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8078651533 |
| Fax |
|
| Email |
amitmttl60@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia RNT Medical College udaipur |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesia RNT Medical College udaipur |
| Address |
RNT Medical college udaipur |
| 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 Amit Mittal |
MB Govt. Hospital, RNT Medical College, UDAIPUR |
Main General Surgery O.T., 2ND FLOOR,MB Govt. Hospital
Udaipur
RAJASTHAN |
9610070967
amitmttl60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT MEDICAL COLLEGE & CONTROLLER & 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, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ropivacaine with clonidine |
USG guided local injection of ropivacaine 0.35%, 19ml diluted up to 20ml in normal saline & clonidine 1mcg/kg in ipsilateral paravertibral space by 23G spinocain at T4 level for single time |
| Comparator Agent |
Ropivacaine.35% |
USG guided local injection of Ropivacaine.35% 19ml diluted up to 20 ml with Normal saline in ipsilateral paravertibral space by 23G spinocain at T4 level for single time |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients who are 18-60 year of age, ASA grade I and II, Normotensives or treated Hypertensives who will undergo MRM surgery will be included in the study |
|
| ExclusionCriteria |
| Details |
Patient refusal,Patients with ASA III and higher,Patient having allergy to study drugs, Coagulation disorders,History of cardiovascular disease, Uncontrolled blood pressure,Pregnancy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DURATION OF ANALGESIA |
up to 24 hrs after completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| THE RESCUE ANALGESIC REQUIREMENT |
OVER FIRST 24 HRS POSTOPERATIVELY |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
20/09/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this trial to find out minimum concentration of ropivacaine with clonidine for better Post operative analgesia in modified redical mastectomy |