| CTRI Number |
CTRI/2021/02/031140 [Registered on: 09/02/2021] Trial Registered Prospectively |
| Last Modified On: |
02/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess and compare the post- operative analgesic effect of wound infiltration with bupivacaine versus mixture of bupivacaine and tramadol undergoing caesarean section under spinal anaesthesia. |
|
Scientific Title of Study
|
Post Operative Analgesic Effect of Wound infiltration with Bupivacaine versus mixture of Bupivacaine and Tramadol in Caesarean Section under Spinal anaesthesia: A Randomized, Double Blind, Interventional Study at S.M.S. Medical College and Attached Hospitals, Jaipur during year 2020-22. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr TRISHALA JAIN |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
S.M.S. Medical College Jaipur |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College
And Attached Hospitals, Adarsh Nagar, Jaipur.
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414281744 |
| Fax |
|
| Email |
trishala.jain31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr TRISHALA JAIN |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
S.M.S. Medical College Jaipur |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College
And Attached Hospitals, Adarsh Nagar, Jaipur.
Jaipur
RAJASTHAN
302004
India
RAJASTHAN
302004
India |
| Phone |
9414281744 |
| Fax |
|
| Email |
trishala.jain31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MAHESH KUMAR |
| Designation |
Junior Resident |
| Affiliation |
S.M.S. Medical College Jaipur |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College
And Attached Hospitals, Adarsh Nagar, Jaipur.
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
|
| Fax |
|
| Email |
messisharma24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Sawai Man Singh Medical College And Attached Hospitals,
Jaipur. |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology Sawai Man Singh Medical College And Attached Hospitals Jaipur |
| Address |
JLN Marg, Adarsh Nagar, Jaipur.
|
| 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 MAHESH KUMAR |
S.M.S. MEDICAL COLLEGE AND ATTACHED HOSPITALS |
DEPTT. OF ANAESTHESIOLOGY
JLN MARG, ADARSH
NAGAR,JAIPUR.
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
7042293980
messisharma24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College and Attached Hospital, Jaipur |
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 |
| Intervention |
injection Bupivacaine 0.25% |
Subcutaneous infiltration by injection Bupivacaine 0.25% at incision site(total dose 20 ml) |
| Comparator Agent |
injection Bupivacaine 0.25% mixed with tramadol 2mg/kg |
Subcutaneous infiltration by injection Bupivacaine 0.25% mixed with tramadol 2mg/kg at incision site(total dose 20 ml) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients undergoing caesarean section under
spinal anesthesia.
2.Patients willing to give written informed
consent.
3.Age 18 to 35 years.
4.Height 145 to 165 cm.
5.Weight from 40 to 70 kg.
6.Patients with ASA grade I and II.
|
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate in the
study.
2.Uncooperative patients.
3.Immuno-compromise patients.
4.Patients with severe cardiopulmonary, renal or liver disease, pre- eclampsia, eclampsia, morbidly obese, bleeding or coagulation disorders.
5. Patients allergic to drugs used in study.
6. Cases with sepsis, bacteremia or skin infection of local site.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the difference between mean time for need of first rescue analgesic in both groups. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Difference in change in hemodynamic variable from baseline to postoperative period in both groups.
2.Difference in percentage of patients who develop side effects in both groups.
|
24 hours |
|
|
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)
|
15/02/2021 |
| 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="3"
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
|
By studying and comparing effects of above mentioned does of Bupivacaine and Tramadol as subcutaneous infiltrations at incision site in caesarean section under spinal anaesthesia will help us to be more efficient in providing best anaesthesia possible to the patient and open up to more research
projects |