| CTRI Number |
CTRI/2024/02/063084 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ketamine with bupivacaine vs bupivacaine analgesia in breast surgeries |
|
Scientific Title of Study
|
A Randomized Prospective study to see the Efficacy and Safety of KETAMINE added to BUPIVACAINE 0.25% in USG guided Modified Pectoral Block for management of postoperative pain in patients undergoing Modified Radical Mastectomy |
| 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 VEENA PATODI |
| Designation |
Senior Professor |
| Affiliation |
Jawahar Lal Nehru medical college |
| Address |
Department of Anaesthesiology Nee OT,1st floor Jawahar Lal Nehru Medical College and Hospitals
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VEENA PATODI |
| Designation |
Senior Professor |
| Affiliation |
Jawahar Lal Nehru Medical College |
| Address |
Department of Anaesthesiology New OT 1st floor Jawaharlal Nehru Medical College and Hospitals
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VEENA PATODI |
| Designation |
Senior Professor |
| Affiliation |
Jawahar Lal Nehru medical college |
| Address |
Department of Anaesthesiology New OT 1st floor Jawahar Lal Nehru Medical College and Hospitals
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology Jawahar lal nehru medical college ajmer |
|
|
Primary Sponsor
|
| Name |
Jawahar Lal Nehru Medical College |
| Address |
Department of Anaesthesia,New OT 1st floor Jawahar Lal Nehru Medical College and hospital building kalabagh Ajmer 305001 |
| 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 |
| DrKIRAN |
Jawahar Lal Nehru Medical College |
Department Of Anaesthesiology ,New OT 1st floor Jawahar Lal Nehru Medical College hospital building kalabagh Ajmer
Ajmer
RAJASTHAN |
8281740024
kiranmohanakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Jawahar Lal Nehru Medical College and Hospitals Ajmer |
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 |
Bupivacaine |
efore surgical resection patients will be receiving the study drugs according to group allocated. Patients will be randomly allocated to group BK using table of randomisation. will be receiving Inj.Bupivacaine 0.25% 30 ml as USG guided infiltration in to pectoral space as single time infiltration. Patients will be followed for duration of analgesia and haemodynamic effects till first complain of pain sensation or 1st demand of rescue analgesia in postoperative period. |
| Intervention |
ketamine with bupivacaine |
Before surgical resection patients will be receiving the study drugs according to group allocated. Patients will be randomly allocated to group BK using table of randomisation. will be receiving Inj.Bupivacaine 0.25% 29 ml + Inj.Ketamine 50mg (1ml) as USG guided infiltration in to pectoral space as single time infiltration. Patients will be followed for duration of analgesia and haemodynamic effects till first complain of pain sensation or 1st demand for analgesia in postoperative period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.females undergoing breast
cancer surgery.
2.ASA grade I and II. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.Deranged coagulation profile.
3.History of opioid use or addiction.
4.Obesity
5.Pregnancy. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of analgesia |
immediate post operation baseline, 30mnts,1hr,2hr,4hr,6hr,12hr,24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Total postoperative analgesic consumption.
2.Haemodynamic variable and side effects |
immediate post operation baseline, 30mnts,1hr,2hr,4hr,6hr,12hr,24hr |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/03/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
With due approval from institutional ethical committee study will be conducted on 80 female breast carcinoma patients undergoing Modified Radical Mastectomy under General Anaesthesia. A written informed consent will be taken prior to procedure. Participants will be alotted into two groups, Group B will be receiving USG guided infiltration of inj Bupivacaine 0.25% 30ml as Pectoral Block and Group BK will be receiving USG guided infiltration of inj Bupivacaine 0.25% 29ml with inj Ketamine 50mg(1ml) as Pectoral block prior to surgery. Participants will be followed in postoperative period for the duration of analgesia, total analegesia consumption, haemodynamic side effects till patients first complain of pain or demands for analgesia . Data will be recorded and analysed using standard qualitative and quantitative tests , the p value of less than 0.05 will be considered significant. |