| CTRI Number |
CTRI/2022/08/044656 [Registered on: 04/08/2022] Trial Registered Prospectively |
| Last Modified On: |
25/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare different effects and fall in blood pressure of spinal anesthesia while using the following drugs
1. fentanyl and bupivacaine together
2. fentanyl after bupivacaine
3. bupivacaine after fentanyl
in orthopedic surgeries of lower limb. |
|
Scientific Title of Study
|
Comparison of Efficacy of premixed versus succedent administration of fentanyl and bupivacaine in subarachnoid block in lower limb surgeries: A prospective double blinded randomized interventional study at S.M.S. Medical College, Jaipur during 2021-2023. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SAVITA MEENA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College And Attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302004
India |
| Phone |
8290969216 |
| Fax |
|
| Email |
drsavita020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SAVITA MEENA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College And Attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302004
India |
| Phone |
8290969216 |
| Fax |
|
| Email |
drsavita020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College And Attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9810797998 |
| Fax |
|
| Email |
drruchi93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology awai Man Singh Medical College And Attached Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Sawai Man Singh Medical College And Attached Hospitals |
| Address |
JLN Marg, Adarsh Nagar, Jaipur |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchi |
Sawai Man Singh Medical College And Attached Hospitals |
Department Of Anaesthesiology, 2nd Floor, Dhanwantari Building, SMS Medical College And Attached Hospitals,JLN Marg , Adarsh Nagar, Jaipur.
Jaipur
RAJASTHAN |
9810797998
drruchi93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sawai Man Singh Medical College and Attached Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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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 0.5% 2.5ml and injection fentanyl 0.5ml in different syringes |
Injection fentanyl 0.5 ml followed by injection bupivacaine 0.5% 2.5ml intrathecally in subarachnoid block |
| Intervention |
Injection bupivacaine 0.5% 2.5ml and injection fentanyl 0.5ml in different syringes |
Injection bupivacaine 0.5% 2.5ml followed by injection fentanyl 0.5ml intrathecally in subarachnoid block |
| Comparator Agent |
Injection bupivacaine 0.5% and injection fentanyl 0.5ml in single syringe |
Injection bupivacaine 0.5% 2.5ml and injection fentanyl 0.5ml premixed in single syringe intrathecally in subarachnoid block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group between 18 to 70 years
2 ASA Grade 1 and 2
3. Body weight 45 to 70 kg
4. Undergoing lower limb surgeries like orthopedic procedures |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in the study.
2. Cases with sepsis, bacteremia or skin infection of local site.
3. Hitory of hypovolemia, anemia and compromised renal, cardiac or respiratory status.
4. Cases with increased intracranial tension.
5. History of blood coagulopathy.
6. Patients allergic to drugs used for study.
7. Failure of spinal anaesthesia. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in mean time of onset of sensory and motor block in three different groups. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the difference in mean time of two segment regression of sensory levels.
2. To determine the difference in change in hemodynamic changes from baseline to different time interval in three groups. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/08/2022 |
| 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
|
This study will help us to find the mean time of onset of sensory and motor block ,hemodynamic changes by using injection bupivacaine and injection fentanyl in different sequences in subarachnoid block. |