| CTRI Number |
CTRI/2024/11/077467 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
To compare the efficacy of two drugs (local anaesthetics) during spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of intrathecal isobaric levobupivacaine versus hyperbaric levobupivacaine in lower abdominal surgeries |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Senthil |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15, Department of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rasika Priya M |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15, Department of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
8129340367 |
| Fax |
|
| Email |
rasikamadhan1985@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Brahmani |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15, Department of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
9972699415 |
| Fax |
|
| Email |
brahmaniperisetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Salem - 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Chinnaseeragapadi, Salem-636308 |
| 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 P Brahmani |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
Room number 15, Department of Anaesthesiology
Salem
TAMIL NADU |
9972699415
brahmaniperisetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Vinayaka missions kirupanandha variyar medical college and hospitals,salem |
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 |
Comparison between isobaric and hyperbaric local anaesthetic drugs |
Comparison of single shot intrathecal 0.5% isobaric levobupivacaine 3.5 ml versus
single shot 0.5% hyperbaric levobupivacaine in lower
abdominal surgeries. Total duration-3hrs intra operatively and 1 hour post operatively |
| Comparator Agent |
Hyperbaric Levobupivacaine |
Single shot 0.5% Hyperbaric Levobupivacaine 3.5 ml intrathecally |
| Comparator Agent |
Isobaric Levobupivacaine |
Single shot 0.5% Isobaric Levobupivacaine 3.5 ml intrathecally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade I, II, III
2. Mallampatti Grading 1, 2
3. Patient giving valid informed consent
4. Lower abdominal surgeries |
|
| ExclusionCriteria |
| Details |
1. ASA Grade IV
2. Mallampatti Grading 3, 4
3. Patient refusal
4. Patient with local infection at puncture site
5. Patient with ischaemic and rheumatic heart disease
6. Patient with coagulation defects and on anticoagulants
7. Patient allergic to local anaesthetic drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the quality of sensory and motor blocks in terms of onset, time, total duration and maximum level attainment |
From 0 minutes of administering spinal anaesthesia upto 60 minute postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness & hemodynamic stability between intrathecal isobaric levobupivacaine versus hyperbaric levobupivacaine in lower abdominal surgeries |
From 0 minutes of administering spinal anaesthesia upto 60 minute postoperatively |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - -
- For how long will this data be available start date provided 05-12-2024 and end date provided 20-11-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This is a randomised controlled trial comparing the quality of sensory and motor block in terms of onset, time, total duration and maximum level attainment followed by assessing the hemodynamic stability between intrathecal isobaric levobupivacaine versus hyperbaric levobupivacaine in lower abdominal surgeries
|