| CTRI Number |
CTRI/2024/08/072640 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| 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 three different spinal drugs for hernia surgery cases - Drugs Bupivacaine, ropivacaine and Levobupivacaine. |
|
Scientific Title of Study
|
Comparison of intrathecal Ropivacaine, Levobupivacaine and Bupivacaine for elective hernioplasty: A prospective randomised controlled 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 |
A. Anusha |
| Designation |
Assistant professor |
| Affiliation |
Bhaarath medical college and hospital |
| Address |
F4, BHEL nagar, Medavakkam, Chennai.
Chennai
TAMIL NADU
600100
India |
| Phone |
9003517979 |
| Fax |
|
| Email |
anushaambal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A. Anusha |
| Designation |
Assistant professor |
| Affiliation |
Bhaarath medical college and hospital |
| Address |
F4, BHEL nagar, Medavakkam, Chennai.
TAMIL NADU
600100
India |
| Phone |
9003517979 |
| Fax |
|
| Email |
anushaambal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A. Anusha |
| Designation |
Assistant professor |
| Affiliation |
Bhaarath medical college and hospital |
| Address |
F4, BHEL nagar, Medavakkam, Chennai.
TAMIL NADU
600100
India |
| Phone |
9003517979 |
| Fax |
|
| Email |
anushaambal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaarath medical college and hospital. |
|
|
Primary Sponsor
|
| Name |
Dr A Anusha |
| Address |
F4, BHEL nagar, Medavakkam, Chennai. |
| 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 A Anusha |
Bhaarath medical college and hospital |
173, Agaram main road, Selaiyur, Chennai.
Chennai
TAMIL NADU |
9003517979
anushaambal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaarath Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
spinal anesthesia |
intervention in spinal anesthesia is tried and data compared with 3 different hyperbaric drugs for their onset, duration and maximum level. |
| Comparator Agent |
spinal anesthesia |
spinal anesthesia with 0.5% hyperbaric Bupivacaine is compared |
| Comparator Agent |
spinal anesthesia |
spinal anesthesia with 0.5% Hyperbaric levobupivacaine is compared |
| Comparator Agent |
spinal anesthesia |
spinal anesthesia with 0.75% hyperbaric Ropivacaine is compared |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II patients |
|
| ExclusionCriteria |
| Details |
Allergic to local anesthetics
Unwilling for spinal anesthesia
Local site infection
Coagulopathy
Patients with cardiac, respiratory and hepatic diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory and motor blockade |
spinal time, 1st hour, 2nd hour, 3rd hour, every hourly till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Onset time of sensory and motor blockade
-Maximum sensory and motor level achieved |
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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
|
Patients who meet the inclusion criteria will be enrolled in the study until adequate sample size is achieved. They will be randomly divided into Groups R, L, B and they will receive 0.75% hyperbaric Ropivacaine, 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric Bupivacaine respectively. Code numbers will be written on patients proforma sheet and decoding will be done by the statistician at the end of the study. 3ml of local anesthetic will be given by an anesthetist who is not involved in the study. Data will be recorded by the investigator who is blinded to the drug injected. The onset of sensory blockade is when the patient complains of no pinprick sensation at T10. The highest level of sensory blockade achieved in each group will be noted. Time after injection of intrathecal
injection of LA to the injection of first dose of rescue analgesia (Inj. Paracetamol 1gm)
will be considered as duration of analgesia. The time of onset of motor blockade will be noted when
patient attains bromage 3. The highest level of motor blockade achieved in
each group will be noted. Duration of motor blockade is the time from spinal anesthesia till the patient is able to flex at the hip level i.e., bromage 0. |