| CTRI Number |
CTRI/2025/09/094413 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to study the effect of two different drugs deposited in spinal CSF for patients undergoing below umbilical operations for kidney related problems. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY
BETWEEN ISOBARIC LEVOBUPIVACAINE WITH HYPERBARIC BUPIVACAINE
IN UROLOGIC SURGERIES: 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 |
SNEHA ANAND |
| Designation |
1 ST YEAR POSTGRADUATE |
| Affiliation |
SREE VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, MAIN OT COMPLEX,13-A, PONDY-VILLUPURAM MAIN ROAD,SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR, PUDUCHERRY.
PONDICHERRY
INDIA
DEPARTMENT OF ANESTHESIOLOGY, MAIN OT COMPLEX,13-A, PONDY-VILLUPURAM MAIN ROAD,SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR, PUDUCHERRY.
PONDICHERRY
INDIA
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9840644833 |
| Fax |
|
| Email |
sneha.doc99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S CHANDRALEELA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR, PUDUCHERRY. |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, MAIN OT COMPLEX,13 A PONDY VILLUPURAM MAIN ROAD SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE ARIYUR, PUDUCHERRY
PONDICHERRY
INDIA
SAME AS ADDRESS 1
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9176529672 |
| Fax |
|
| Email |
drchanduz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S CHANDRALEELA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR, PUDUCHERRY. |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, MAIN OT COMPLEX,13 A PONDY VILLUPURAM MAIN ROAD SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE ARIYUR, PUDUCHERRY
PONDICHERRY
INDIA
SAME AS ADDRESS 1
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9176529672 |
| Fax |
|
| Email |
drchanduz@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SNEHA ANAND |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, MAIN OT COMPLEX,13-A, PONDY-VILLUPURAM MAIN ROAD,SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR, PUDUCHERRY. |
| 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 Sneha Anand |
SREE VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
DEPARTMENT OF ANESTHESIOLOGY, MAIN OT COMPLEX, ROOM NO.8[UROLOGY OT]
Ariyur
Pondicherry
PONDICHERRY |
9840644833
sneha.doc99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee(HumanStudies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N218||Other lower urinary tract calculus, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HYPERBARIC BUPIVACAINE |
MULTI PARA MONITORS ATTACHED TO PATIENTS, UNDER ASEPTIC PRECAUTIONS HYPERBARIC BUPIVACAINE IS ADMINISTERED. THE ONSET, DURATION OF SENSORY AND MOTOR BLOCKADE, HEMODYNAMIC STABILITY ARE MONITORED AND COMPARED BETWEEN GROUP 1 AND GROUP 2 . HERE GROUP 2 IS PATIENTS RECEIVING HYPERBARIC BUPIVACAINE |
| Intervention |
ISOBARIC LEVOBUPIVACAINE |
MULTI PARA MONITORS ATTACHED TO PATIENTS, UNDER ASEPTIC PRECAUTIONS ISOBARIC LEVOBUPIVACAINE IS ADMINISTERED.
THE ONSET, DURATION OF SENSORY AND MOTOR BLOCKADE, HEMODYNAMIC STABILITY ARE MONITORED AND COMPARED BETWEEN GROUP 1 AND GROUP 2 . HERE GROUP 1 IS PATIENTS RECEIVING ISOBARIC LEVOBUPIVACAINE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS POSTED FOR ELECTIVE UROLOGIC SURGERIES UNDER SPINAL ANESTHESIA
AGE GROUP OF 18-65 YEARS OF AGE
BELONGING TO ASA CLASS I AND CLASS II |
|
| ExclusionCriteria |
| Details |
Patient refusal to spinal anesthesia
Contraindications to spinal anesthesia like
Bleeding disorders and coagulation abnormalities
Raised Intracranial pressure
Having neurological deficits
History of severe migraine and headache
|
|
|
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 onset, duration of sensory and motor blockade in
patients receiving 0.5% isobaric Levobupivacaine [group L] and patients receiving 0.5%
hyperbaric Bupivacaine [group B] in patients undergoing urologic surgeries. |
MODIFIED BROMAGE SCALE HR, SBP, DBP, MAP, ECG, RR, SPO2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the intraoperative hemodynamic changes between two groups
To evaluate the adverse effects between the groups |
HR, SBP, DBP, MAP, ECG, RR, SPO2 |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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="1"
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
|
SPINAL ANESTHESIA PLAYS A PIVOTAL ROLE IN MODERN SURGICAL PRACTICE, OFFERING INTRAOPERATIVEANESTHESIA AND POSTOPERATIVE ANALGESIA WHILE MINIMISING SYSTEMIC SIDE EFFECTS. IN UROLOGICAL SURGERIES SPINAL ANESTHESIA IS THE PREFERRED TECHNIQUE DUE TO ITS RAPID ONSET , PREDICTABLE EFFECT AND COST EFFECTIVENESS.A RANDOMISED CONTROLLED DOUBLE BLINDED STUDY IS DONE BETWEEN PATIENTS RECEIVING ISOBARIC LEVOBUPIVACAINE AND HYPERBARIC BUPIVACAINE IN PATIENTS UNDERGOING ELECTIVE UROLOGIC SURGERIES UNDER SPINAL ANESTHESIA. TOTAL SAMPLE SIZE IS 74, WITH 37 PARTICIPANTS IN EACH GROUP. THE INCLUSION AND EXCLUSION CRITERIA ARE FOLLOWED . INFORMED AND WRITTEN CONSENT FROM PATIENTS WILL BE OBTAINED.PATIENTS WILL BE SHIFTED TO OT ,IV ACCESS WILL BE SECURED, ON THE FOREARM ,IV FLUIDS WILL BE STARTED. MULTIPARA MONITORS WILL BE CONNECTED , UNDER ASEPTIC PRECAUTIONS UNDER SPINAL ANESTHESIA THE DRUG WILL BE ADMINISTERED .HEART RATE , BP, ECG, RR, SPO2, VAS SCALE MODIFIED BROMAGE SCALE ARE MONITORED AND STUDIED. |