| CTRI Number |
CTRI/2024/12/078272 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare and assess among participants receiving intrathecal 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric bupivacaine for lower abdominal surgeries among 70 participants in each group. |
|
Scientific Title of Study
|
Inthrathecal levobupivacaine vs bupivacaine for infraumbilical surgery:A randomized control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alif Al Mohammed M |
| Designation |
Junior Resident |
| Affiliation |
JSS Academy of Higher Education |
| Address |
Department of Anaesthesia
JSS Hospital ,Mysore, KARNATAKA
Mysore
KARNATAKA
570004
India |
| Phone |
9496346228 |
| Fax |
|
| Email |
alifalmuhammed123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dinesh Kumar |
| Designation |
Associate Professor |
| Affiliation |
JSS Hospital Mysuru |
| Address |
Consultant cardiac Anaesthesiologist
Department of Anaesthesia
JSS Medical college ,Mysore Karnataka
Mysore
KARNATAKA
570004
India |
| Phone |
9663237722 |
| Fax |
|
| Email |
drdinu80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Dinesh Kumar |
| Designation |
Associate Professor |
| Affiliation |
JSS Hospital Mysore |
| Address |
Consultant cardiac Anaesthesiologist
Department of Anaesthesia
JSS Medical college, Mysore, Karnataka
KARNATAKA
570004
India |
| Phone |
9663237722 |
| Fax |
|
| Email |
drdinu80@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Medical college and Hospital ,Mysore,karnataka ,570004,India |
|
|
Primary Sponsor
|
| Name |
JSS Academy of Higher Education and Research |
| Address |
JSS Medical college and Hospital ,MYSORE,karnataka 570004,India |
| 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 Alif Al Mohammed M |
JSS MEDICAL COLLEGE AND HOSPITAL |
Operation theatre complex third floor ,JSS hospital MG road ,Agrahara, Mysore, Karnataka
Mysore
KARNATAKA |
9496346228
alifalmuhammed123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS MEDICAL COLLEGE |
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% hyperbaric bupivacaine 3ml and 0.5% hyperbaric levobupivacaine 3ml intrathecally |
1.After lumbar puncture 0.5% hyperbaric bupivacaine 3ml given intrathecally
2.After lumbar puncture 0.5% hyperbaric levobupivacaine and noted at 0 minute,5 minute till 330 minutes |
| Comparator Agent |
0.5% hyperbaric levobupivacaine 3ml and 0.5% hyperbaric bupivacaine 3ml intrathecally |
1.After lumbar puncture 0.5% hyperbaric levo bupivacaine 3ml given intrathecally 2.After lumbar puncture 0.5 % hyperbaric bupivacaine 3ml given intrathecally and noted at o minutes ,5 minutes till 330 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
age :18-60 yrs,either sex ,ASA 1 and 2,patients undergoing infraumbilical surgery under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
spinal anomalies,contraindications to spinal anaesthesia, ASA 3 and 4,deranged coagulation profile,local infection at the surgical site |
|
|
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 compare the sensory and motor block of 0.5% hyperbaric levo bupivacaine and o.5% hperbaric bupivacaine |
From time of spinal anaesthesia and noted at 0 minutes,5 minutes till 330 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses the sensory & motor block onset time ,total duration,asses & compare the side effects of hyperbaric bupivacaine & levobupivacaine |
From the time of spinal anesthesia & noted at 0 minutes,5 minutes till 330 minutes.Till the patient feel pain at incision site |
|
|
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)
|
29/12/2024 |
| 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="6"
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
|
All the patients will be admitted before surgery and pre anesthetic evaluation will be done.
After obtaining informed consent patients of ASA I and II either gender undergoing elective infra umbilical surgery in whom spinal anesthesia is indicated will be include in the study.
On the day of surgery .in the operation theater ASA monitoring device will be attached and baseline recordings will be recorded
With patient sitting position lumbar puncture performed at L2-l3 level or L3-L4 level and the study drug is injected intra thecally and asses sensory and motor block onset time ,total duration of sensory and motor block,duration of effective analgesia and anesthesia
Hypotension and bradycardia also will noted down and treated accordingly
The study will also asses side effects such as nausea and vomiting |