| CTRI Number |
CTRI/2018/11/016311 [Registered on: 09/11/2018] Trial Registered Prospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO CHECK THE PAIN RELIVING ACTION OF ROPIVACAINE VERSUS LEVOBUPIVACAINE IN PATIENT UNDERGOING BREAST SURGERY. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF POST OPERATIVE ANALGESIC EFFECTS OF WOUND INFILTRATION WITH ROPIVACAINE VERSUS LEVOBUPIVACAINE IN MODIFIED RADICAL MASTECTOMY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VB Gowda |
| Designation |
Professor |
| Affiliation |
Kidwai Cancer Institute |
| Address |
Department of Anesthesiology
Kidwai Cancer Institute
Dr M H Marigowda road
Bangalore 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9845259264 |
| Fax |
|
| Email |
vbchethana@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VB Gowda |
| Designation |
Professor |
| Affiliation |
Kidwai Cancer Institute |
| Address |
Department of Anesthesiology
Kidwai Cancer Institute
Dr M H Marigowda road
Bangalore 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9845259264 |
| Fax |
|
| Email |
vbchethana@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
JEAN HANNAH PHILIP |
| Designation |
Post graduate student, DNB |
| Affiliation |
Kidwai Cancer Institute |
| Address |
Womens post graduate hostel
Kidwai Cancer Institute
Dr M H Marigowda road
Bangalore 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
7293564005 |
| Fax |
|
| Email |
jeanhannah91@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANESTHESIOLOGY KIDWAI CANCER INSTITUTE
Dr M Have Marigowda road
Bangalore 560029 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology kidwai Cancer Institute |
| Address |
Department of Anesthesiology
Kidwai Cancer Institute
Dr M H Marigowda road
Bangalore 560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| JEAN HANNAH PHILIP |
KIDWAI CANCER INSTITUTE |
Room 105
Department of Anesthesiology
Kidwai Cancer Institute
Dr M H Marigowda road
Bangalore 560029
Bangalore
KARNATAKA |
7293564005
jeanhannah91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, kidwai Cancer Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LEVOBUPIVACAINE |
0.5% ACCORDING TO BODY WEIGHT WOUND INFILTRATION
SINGLE DOSE AT END OF SURGERY
OBSERVED UPTO 24HOURS |
| Intervention |
ROPIVACAINE |
0.75% ACCORDING TO BODY WEIGHT WOUND INFILTRATION
SINGLE DOSE AT END OF SURGERY
OBSERVED UPTO 24HOURS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 and 2
Consenting patient
Weight 50-70kg |
|
| ExclusionCriteria |
| Details |
Patient refusal
History of allergy
Severe renal liver cardiac and pulmonary dysfunction
Unable to comprehend VAS scale |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analgesic efficacy VAS scale |
Post operatively 0min, 15min, 30min, 45min, 60min,90min,2,4,8,12,16,20 and 24hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Requirements of rescue analgesia
Incidence and severity of side effect |
Post operative period in first 24hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/11/2018 |
| Date of Study Completion (India) |
16/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/05/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Adequate post operative analgesia with minimal side effects is major concern of post anaesthesia care. Ropivacaine known to be significantly lower toxic effect than racemic Bupivacaine, it is less potent than Bupivacaine when used at equal concentration. Levobupivacine the s enantiomer of racemic Bupivacaine is associated with greater safety with regard to cardiotoxic and neurotoxicity. It is also found that it is equipotent to racemic Bupivacaine. This prospective study is proposed to compare analgesic efficacy in modified radical mastectomy. |