| CTRI Number |
CTRI/2025/08/093543 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of changes intraoperatively between 0.5 percent hyperbaric bupivacaine and 0.75 percent hyperbaric ropivacaine in spinal anaesthesia- a RCT |
|
Scientific Title of Study
|
Study of intraoperative hemodynamic changes between 0.5 percent Hyperbaric Levobupivacaine and 0.75 percent Hyperbaric Ropivacaine in subarachnoid block- a RCT |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annanya Tripathy |
| Designation |
Post Graduate Trainee Anaesthesia |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES (KIMS) KIIT DEEMED TO BE UNIVERSITY |
| Address |
OT COMPLEX, 3RD FLOOR,Kalinga institue of medical science, Kushabhadra Campus, 5, Kiit Road, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751016
India |
| Phone |
7008624587 |
| Fax |
|
| Email |
2487012@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Lingaraj Sahu |
| Designation |
Professor, Dept. of Anaesthesiology KIMS |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES (KIMS) KIIT DEEMED TO BE UNIVERSITY |
| Address |
OT COMPLEX, 3RD FLOOR,Kalinga institue of medical science, Kushabhadra Campus, 5, Kiit Road, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751031
India |
| Phone |
8280166501 |
| Fax |
|
| Email |
lingaraj.sahu@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Lingaraj Sahu |
| Designation |
Professor, Dept. of Anaesthesiology KIMS |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES (KIMS) KIIT DEEMED TO BE UNIVERSITY |
| Address |
OT COMPLEX, 3RD FLOOR,Kalinga institue of medical science, Kushabhadra Campus, 5, Kiit Road, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751031
India |
| Phone |
8280166501 |
| Fax |
|
| Email |
lingaraj.sahu@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| KALINGA INSTITUTE OF MEDICAL SCIENCES (KIMS) KIIT DEEMED TO BE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
Dr Annanya Tripathy |
| Address |
OT COMPLEX, 3RD FLOOR,Kalinga institue of medical science, Kushabhadra Campus, 5, Kiit Road, Bhubaneswar, Odisha 751024
|
| 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 ANNANYA TRIPATHY |
KALINGA INSTITUTE OF MEDICAL SCIENCES (KIMS) KIIT DEEMED TO BE UNIVERSITY |
ROOM NO-12,3RD FLOOR, DEPT OF ANAESTHESIA,KIMS, KIIT Campus 5, KIIT, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA |
7008624587
2487012@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ,KALINGA INSTITUE OF MEDICAL SCIENCE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S821||Fracture of upper end of tibia, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric Levobupivacaine |
3ml of 0.5% Hyperbaric Levobupivacaine during subarachnoid block |
| Intervention |
HYPERBARIC ROPIVACINE
|
3ml of 0.75% Hyperbaric Ropivacaine, during subarachnoid block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient posted for elective surgery under spinal anaesthesia.
2.Patients giving consent for the study
3.American Society of Anaesthesiologists (ASA) physical status I
|
|
| ExclusionCriteria |
| Details |
Known allergy to drugs used in the study.
Patients with local skin infections at the site of injection
Patients with spine deformity
Surgeries requiring more than 3 hrs
Patients with surgical complications like intra-operative bleeding change in surgical plan, extending duration of surgery or change of anesthetic plan to General Anaesthesia(GA) due to surgical requirements
|
|
|
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 |
| To compare the intraoperative hemodynamic changes between two groups i.e Hyperbaric Levobupivacaine versus Hyperbaric Ropivacaine in spinal anaesthesia |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare and evaluate
Duration of sensory blockade
|
2 years |
| Duration of motor blockade |
2 years |
|
|
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)
|
03/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
THE PRIMARY PURPOSE OF STUDY IS TO COMPARE THE INTRAOPERATIVE HEMODYNAMIC STABILITY BETWEEN 0.5% HYPERBARIC LEVOBUPIVACAINE AND 0.75 HYPERBARIC ROPIVACAINE WHEN USED FOR SPINAL ANESTHESIA IN ELECTIVE SURGERIES.THE STUDY ALSO AIMS TO EVALUATE DIFFERENCES IN SENSORY AND MOTOR DURATION BETWEEN THE TWO AGENTS. IT IS HYPOTHESIZED THAT HYPERBARIC ROPIVACAINE PROVIDES COMPARABLE OR SUPERIOR HEMODYNAMIC STABILITY THAN HYPERBARIC LEVOBUPIVACAINE |