| CTRI Number |
CTRI/2024/07/071753 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Assess the Effect of Speed of Injection of 0.5% Heavy Bupivacaine on Quality of Block and Hemodynamic Parameters in Patients Scheduled for Infra Umbilical Surgeries Under Spinal Anesthesia. |
|
Scientific Title of Study
|
A Randomized Double-Blind Study to Compare the Effect of Speed of Injection (15 sec versus 60 sec) of 0.5% Heavy Bupivacaine on Quality of Block And Hemodynamic Parameters in Patients Scheduled for Infra Umbilical Surgery Under Spinal Anesthesia. |
| 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 Kanchan Chauhan |
| Designation |
Senior Professor |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anaesthesiology Operation Theatre 2 SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanchan Chauhan |
| Designation |
Senior Professor |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anaesthesiology Operation Theatre 2 SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul kachhwaha |
| Designation |
Resident Doctor |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anaesthesiology Operation Theatre 2 SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
8058432771 |
| Fax |
|
| Email |
rahulkachhwaha2091@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN INDIA -302004 |
|
|
Primary Sponsor
|
| Name |
SMS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN 302004 |
| 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 Kanchan chauhan |
SMS MEDICAL COLLEGE AND HOSPITAL |
Department of Anaesthesiology Operation Theatre 2 SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN |
8107872222
kanchan2371@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of The Ethics Committee SMS Medical College and Attached Hospitals 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 |
0.5% Heavy Bupivacaine |
Patients will be given Subarachnoid Block with 3 ml of 0.5% Heavy Bupivacaine in 15 Seconds. |
| Comparator Agent |
0.5% Heavy Bupivacaine |
Patients will be given Subarachnoid Block with 3 ml of 0.5% Heavy Bupivacaine in 60 Seconds. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex scheduled to undergo elective infra umbilical surgical procedure under spinal anaesthesia.
Patient giving written informed consent.
ASA Grade I and II. |
|
| ExclusionCriteria |
| Details |
Patient who is part of any other study.
Non co-operative patient.
Patients with infection at the injection site.
Patients with thrombocytopenia or coagulopathy.
Patients with allergy to study drug. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean time of onset of sensory block.
Mean time of onset of motor block.
Mean time to achieve T 10 dermatome block.
Mean block height at 5 minutes.
Mean of maximum sensory level achieved.
Mean of haemodynamic parameters (HR,SBP,DBP,MAP).
Mean time taken for onset of hypotension.
Mean dose of Mephentermine required to correct hypotension.
|
Baseline, Just after SAB,2 min,4 min,6 min,8 min,10 min,15 min,20 min,25 min,30 min,35 min,40 min,45 min,50 min,55 min,60 min,65 min,70 min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of cases with side effects (if any). |
Up to 12 hours of surgery. |
|
|
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)
|
01/09/2024 |
| 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="0"
Months="2"
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
|
In anesthetic practice, spinal anesthesia is the most often used technique for gynaecological ,lower abdominal, pelvic and lower limb procedures. The advantage of spinal anesthesia is that it can cause a profound nerve block with only a modest dose of local anesthetic injection. There is a scarcity of data on the effect of speed of injection while administering hyperbaric solutions for spinal block. Although higher distribution of sensory blockade has been observed with a slower speed of injection, most researches using a hyperbaric local anesthetics have not reported difference in anesthetic characteristics. With this background we plan to conduct this study to compare the effect of speed of injection(15 sec versus 60 sec) of 0.5%heavy bupivacaine on quality of block and haemodynamic parameters in patients scheduled for infra umbilical surgery under spinal anesthesia. |