| CTRI Number |
CTRI/2025/01/079554 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two drugs to given along with local anaesthetic in Spinal anesthesia for duration of post op analgesia |
|
Scientific Title of Study
|
Comparison Of Levo-Bupivacaine Fentanyl and Levo-Bupivacaine Fentanyl with Magnesium Sulphate as Adjuvants to Spinal Anaesthesia in Infra-umblical Surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keerthana J |
| Designation |
Assistant Proffessor |
| Affiliation |
ACSMCH |
| Address |
Assistant Proffessor
Department of Anesthesiology
ACS Medical College
Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
8870877244 |
| Fax |
|
| Email |
keerthana_28791@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Keerthana J |
| Designation |
Assistant Proffessor |
| Affiliation |
ACSMCH |
| Address |
Assistant Proffessor
Department of Anesthesiology
ACS Medical College
Chennai
TAMIL NADU
600077
India |
| Phone |
8870877244 |
| Fax |
|
| Email |
keerthana_28791@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Keerthana J |
| Designation |
Assistant Proffessor |
| Affiliation |
ACSMCH |
| Address |
Assistant Proffessor
Department of Anesthesiology
ACS Medical College
Chennai
TAMIL NADU
600077
India |
| Phone |
8870877244 |
| Fax |
|
| Email |
keerthana_28791@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| ACS Medical College & Hospital
Velappanchavadi
Chennai 77 |
|
|
Primary Sponsor
|
| Name |
Keerthana J |
| Address |
No 10 70th street Korattur
Chennai600080 |
| Type of Sponsor |
Other [Self ] |
|
|
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 KeerthanaJ |
ACS Medical College& Hospital |
Department of Anesthesiology
Vellapanchavadi
chennai
Thiruvallur
TAMIL NADU |
8870877244
keerthana_28791@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACS MEDICAL COLLEGE HOSPITAL |
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 |
| Comparator Agent |
Duration of Post- operative analgesia |
comparing duration of post operative analgesia using VAS score. Time of administering first rescue analgesic will be considered as duration of analgesia |
| Intervention |
Spinal Anesthesia |
Persons who are posted for infraumblical surgeries receiving spinal anesthesia will be divided into two groups one group will receive Levo-Bupivacaine with Fentanyl and the other group will receive LevoBupivacaine Fentanyl along with Magnesium Sulpahte |
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Age between 20years to 60 years
All patients undergoing Infraumblical surgery |
|
| ExclusionCriteria |
| Details |
Patients not willing for spinal anesthesia
Patients with severe cardiac diseases
Patients with age less than 20 years and more than 60 years
Patients with coagulopathies
Patients with infections in the spine |
|
|
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 duration of sensory block when intrathecal Magnesium sulphate is added with low doseLevo Bupivacaine Fentanyl Spinal Anesthesia with spinal Anesthesia given only with Levo bupivacaine & Fentanyl |
VAS score will be assessed every 2 hours in the post operative period until it is less than 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the onset of sensory and motor blockade in both the groups |
every minute for first 5 minutes |
|
|
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 4 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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
|
This study is a Randomised double blinded control study in which the participants will equally be divided into 2 groups. The person performing the procedure will be unrealated to the study and will be performing the spinal anesthesia technique with drugs given to him in sealed envelopes. The principle investigator who will be blinded to the drug given will be noting the required paremeters in the post-operative period |