| CTRI Number |
CTRI/2020/11/029140 [Registered on: 16/11/2020] Trial Registered Prospectively |
| Last Modified On: |
13/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of different concentrations of local anesthetic on pain control when given in regional anesthesia (erector spinae plane block)for breast surgery |
|
Scientific Title of Study
|
Comparative evaluation of analgesic efficacy of different concentrations of Levobupivacaine In Ultrasound Guided Erector Spinae Block For Breast Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amanpreet kaur |
| Designation |
Junior resident second year anesthesia |
| Affiliation |
Baba farid university of health sciences |
| Address |
Room no 68 girls hostel medical campus old jail road Faridkot
GGS Medical College And Hospital Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9914949284 |
| Fax |
|
| Email |
docamanpreet@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KEWAL KRISHAN GUPTA |
| Designation |
Associate professor |
| Affiliation |
BFUHS |
| Address |
DEPARTMENT OF ANESTHESIA GURU GOBIND SINGH MEDICAL HOSIPTAL AND COLLEGE FARIDKOT
DEPARTMENT OF ANESTHESIA GURU GOBIND SINGH MEDICAL HOSIPTAL AND COLLEGE FARIDKOT
Faridkot
PUNJAB
151203
India |
| Phone |
9988316306 |
| Fax |
|
| Email |
doc_krishan31@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr sarvjeet kaur |
| Designation |
professor |
| Affiliation |
BFUHS |
| Address |
DEPARTMENT OF ANESTHESIA GURU GOBIND SINGH MEDICAL HOSIPTAL AND COLLEGE FARIDKOT
Faridkot
PUNJAB
151203
India |
| Phone |
|
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, GGS Medical College and Hospital Faridkot Punjab |
|
|
Primary Sponsor
|
| Name |
DrKewal Krishan Gupta |
| Address |
Associate Professor Department of Anaesthesiology GGS Medical College And Hospital Faridkot , Punjab |
| Type of Sponsor |
Other [Guide has ensured that all the facilities for the study are available in the institution ] |
|
|
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 Amanpreet kaur |
Guru Gobind Singh medical college and hospital |
Department of Anaesthesiology Faridkot
Faridkot
PUNJAB |
9914949284
docamanpreet@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of GGS Medical College and Hospital , Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.25% levibupivacaine |
0.25 %levobupivacaine in 20ml saline will be given before induction with general anesthesiatechnique .THE drug will be administered in erector spinae plane.Postoperative analgesia will be assessed |
| Intervention |
0.375% levobupivacaine |
20ml of0.375% %levobupivacaine will be given before induction with standard general anesthesia technique.postoperative analgesia will be assessed |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA I AND II PATIENTS
PATIENTS SCHEDULED FOR BREAST SURGERY |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TOTAL DURATION OF ANALGESIA WILL BE NOTED IN TWO GROUPS POSTOPERATIVELY .IT WILL BE TAKEN FROM TIME OF COMPLETION OF INJECTION TO THE REQUEST OF FIRST RESCUE ANALGESIA |
In the first 24 hours of postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QUALITY OF ANALGESIA |
in postoperative period at 0,2‚4‚8‚12‚18‚24hours |
|
|
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)
|
16/11/2020 |
| 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="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
|
total of 60 patients will be randomly allocated into 2 study groups of 30 patients each .Each group will receive erector spinae block before induction with general anesthesia technique .Group A will recevie 20ml of 0.25%levobupivacaine and Group B will receive 20ml of 0.375% levobupivacaine . Duration of postoperative analgesia in first 24 hours postoperatively will be noted and compared .After completion of study ,observation obtained will be tabulated and analysed using appropriate stastical methods. . |