| CTRI Number |
CTRI/2023/04/051462 [Registered on: 11/04/2023] Trial Registered Prospectively |
| Last Modified On: |
10/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to compare effect of Bupivacaine with Tramadol and Levobupivacaine with Tramadol for pain in below umblical surgeries after operation by epidural catheter. |
|
Scientific Title of Study
|
Comparitive study of Bupivacaine with Tramadol and Levobupivacaine with Tramadol in below umbilical surgeries for post operative epidural analgesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankit Gupta |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
PEOPLES COLLEGE OF MEDICAL SCIENCES & RESEARCH CENTRE BHANPUR BHOPAL |
| Address |
DEPARTMENT OF ANAESTHESIA
PEOPLES MEDICAL COLLEGE
BHANPUR
BHOPAL
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9993007222 |
| Fax |
|
| Email |
ankit.gupta37@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAHIMA BATRA |
| Designation |
PROFESOR |
| Affiliation |
PEOPLES COLLEGE OF MEDICAL SCIENCES & RESEARCH CENTRE BHANPUR BHOPAL |
| Address |
DEPARTMENT OF ANAESTHESIA
PEOPLES MEDICAL COLLEGE
PEOPLES CAMPUS
BHANPUR
BHOPAL
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
975207418 |
| Fax |
|
| Email |
drmahimabatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Gupta |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
PEOPLES COLLEGE OF MEDICAL SCIENCES & RESEARCH CENTRE BHANPUR BHOPAL |
| Address |
DEPARTMENT OF ANAESTHESIA
PEOPLES MEDICAL COLLEGE
PEOPLES CAMPUS
BHANPUR
BHOPAL
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9993007222 |
| Fax |
|
| Email |
ankit.gupta37@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples college of medical sciences,bhopal,madhya pradesh |
|
|
Primary Sponsor
|
| Name |
Peoples University,bhopal,madhya pradesh |
| Address |
Karond Bypass Rd,peoples campus,bhanpur,bhopal,madhya pradesh |
| Type of Sponsor |
Private 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 ANKIT GUPTA |
PEOPLES COLLEGE OF MEDICAL SCIENCES BHOPAL |
PEOPLES UNIVERSITY
KAROND BYPASS ROAD
PEOPLES CAMPUS
BHANPUR
BHOPAL
MADHYA PRADESH
Bhopal
MADHYA PRADESH |
9993007222
ankit.gupta37@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S829||Unspecified fracture of lower leg, (2) ICD-10 Condition: N809||Endometriosis, unspecified, (3) ICD-10 Condition: D269||Other benign neoplasm of uterus, unspecified, (4) ICD-10 Condition: N814||Uterovaginal prolapse, unspecified, (5) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, (6) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (7) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (8) ICD-10 Condition: M879||Osteonecrosis, unspecified, (9) ICD-10 Condition: M163||Unilateral osteoarthritis resulting from hip dysplasia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BUPIVACAINE WITH TRAMADOL |
All the patients having VAS SCORE more then 4 post operatively will be divided into 2 groups.Group 1(BT) will receive 2ml 0.5 percent Bupivacaine with 1ml(50mg) Tramadol diluted up to 10ml with NS via epidural catheter.Pt.can receive maximum 4 doses within 24 hours postoperatively. |
| Comparator Agent |
LEVOBUPIVACAINE AND TRAMADOL |
All the patients having VAS SCORE more then 4 post operatively will be divided into 2 groups.Group 2(LT) will receive 2ml 0.5 percent Levobupivacaine with 1ml(50mg) Tramadol diluted up to 10ml with NS via epidural catheter.Pt.can receive max 4 doses within 24 hours postoperatively.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE 1& 2
SCHEDULE FOR ELECTIVE IN BELOW UMBILICAL SURGERIES THAT REQUIRE POST OPERATIVE EPIDURAL ANALGESIA.
DOSE OF INJ.BUPIVACAINE 3.5ML WITHOUT ADJUVANT.
DURATION OF SURGERY 90-120 MINS. |
|
| ExclusionCriteria |
| Details |
LACK OF PATIENTS CONSENT.
AGE <18YRS & >60YRS.
ASA GRADE 3 AND MORE.
HISTORY OF SERIOUS PULMONARY DISEASE,ISCHEMIC HEART DISEASE,RENAL/HEPATIC DYSFUNCTION,CORONARY ARTERY OR CERVICAL SPINE DISEASE AND PATIENTS WITH ABNORMAL COAGULATION PROFILE.
PATIENTS WITH LOCAL SKIN INFECTIONS.
PATIENTS WITH HYPERSENSITIVITY TO ANY OF THE DRUGS USED.
PREGNANT AND LACTATING MOTHERS.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE NUMBER OF EPIDURAL ANALGESIA (top up) required in first 24 hours in both groups. |
FIRST 24 HOURS AFTER THE SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE HEMODYNAMIC CHNAGES IN THE POST OPRETIVE PERIOD. |
FIRST 24 HOURS AFTER THE SURGERY |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/04/2023 |
| 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
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
POST OPERATIVE PAIN AFTER MAJOR INFRAUMBLICAL SURGERIES IS THE MAINSTAY OF CONCERN ,AS IT CAN INCREASE RISK OF RESPIRATORY & CARDIOVASCULAR COMPLICATIONS AND GASTROINTESTINAL MOTILITY ,AMBULATION & HOSPITAL STAY.EPIDURAL ANALGESIA CAN PROVIDE EXCELLENT POST OPERATIVE ANALGESIA. VARIOUS STUDIES HAVE FOUND THAT DIFFERENT LOCAL ANAESTHETIC CAN PROVIDE ANALGESIA.WE ARE COMPARING EFFECT OF BUPIVACAINE WITH TRAMADOL & LEVOBUPIVACAINE WITH TRAMADOL AS THEY ARE HAVING LOW SIDE EFFECT PROFILE &CAN PROVIDE EXCELLENT POST OPERATIVE ANALGESIC EEFECT FOR FIRST 24 HOURS POST OPERATIVELY IN INFRAUMBLICAL SURGERIES. |