| CTRI Number |
CTRI/2026/03/107046 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/03/2026 |
| 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
|
Comparison of 3 anaesthesia drugs bupivacaine levobupivacaine and ropivacaine given through space in spinal cord for pain relief in short gynaecological surgeries |
|
Scientific Title of Study
|
Comparative study of bupivacaine zero point five percent levobupivacaine zero point five percent and ropivacaine zero point seven five percent in spinal anaesthesia for daycare gynaecological procedures |
| 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 Jini S |
| Designation |
Post graduate student |
| Affiliation |
Shimoga institute of medical sciences |
| Address |
Post graduate student
Department of anaesthesiology
Shimoga institute of medical sciences
Shimoga
Shimoga
KARNATAKA
577201
India |
| Phone |
8129354258 |
| Fax |
|
| Email |
jinishajahan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Hiremath |
| Designation |
Associate Professor |
| Affiliation |
Shimoga institute of medical sciences |
| Address |
Department of Anaesthesiology
shimoga institute of medical sciences
shimoga
Shimoga
KARNATAKA
577201
India |
| Phone |
8197724745 |
| Fax |
|
| Email |
drshrutihiremath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Hiremath |
| Designation |
Associate Professor |
| Affiliation |
Shimoga institute of medical sciences |
| Address |
Department of Anaesthesiology
Shimoga institute of medical sciences
Shimoga
Shimoga
KARNATAKA
577201
India |
| Phone |
8197724745 |
| Fax |
|
| Email |
drshrutihiremath@gmail.com |
|
|
Source of Monetary or Material Support
|
| shimoga institute of medical sciences
shimoga
karnataka
india
577201 |
|
|
Primary Sponsor
|
| Name |
Dr Jini S |
| Address |
Post graduate student
Department of Anesthesiology
Shimoga institute of medical sciences
Shimoga
Karnataka
India
577201 |
| 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 Jini S |
Shimoga institute of medical sciences |
Department of anaesthesiology
Third floor
Shimoga institute of medical sciences
karnataka
india
577201
Shimoga
KARNATAKA |
8129354258
jinishajahan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Spinal anaesthesia |
Subarachnoid block will be done under strict aseptic precautions with patient in left lateral position using twenty five G quinckespinal needle at L three L four interspace and one of the agents will be administered intrathecally after confirmation of free and clear flow of csf patient will be made to lie supine immediately after drug adminstration |
| Comparator Agent |
Zero point five percent hyperbaric bupivacaine one point six millilitre |
In spinal anaesthesia |
| Comparator Agent |
Zero point five percent hyperbaric levobupivacaine one point six millilitre |
In spinal anaesthesia |
| Comparator Agent |
Zero point seven five percent hyperbaric ropivacaine one point six millilitre |
In spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Asa status of one and two
Height more than one forty five centimetres
Written informed consent
Posted for elective gynaecological surgeries |
|
| ExclusionCriteria |
| Details |
History of bleeding diathesis and coagulopathy
Patient refusal and coagulopathy
History of allergy to local anaesthetics
Spinal deformities or neurological disorders
Infection at site of injection
History of clinically relevant respiratory cardiac hepatic disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of zero point five percent hyperbaric bupivacaine zero point five percent hyperbaric levobupivacaine and zero point seven five percent hyperbaric ropivacaine for spinal anaesthesia in daycare gynaecological surgeries with respect to duration of sensory and motor block |
baseline immediately after injection two minutes five minutes ten minutess fifteen minutes twenty minutes thirty minutes sixty minutes ninety miutes one hundred and twenty minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HAEMODYNAMIC CHANGES |
|
| SURGEON SATISFACTION |
|
| PATIENT SATISFACTION |
|
| SIDE EFFECTS IF ANY |
|
| Onset of sensory & motor block |
baseline immediately after injection two minutes five minutes ten minutess fifteen minutes twenty minutes thirty minutes sixty minutes ninety miutes one hundred & twenty minutes |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 |
|
Date of First Enrollment (India)
|
12/04/2026 |
| 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
|
THE USE OF SPINAL ANAESTHESIA IN GYNAECOLOGICAL SURGERIES HAS BEEN SHOWN TO PROVIDE EFFECTIVE AND COMFORTABLE INTRAOPERATIVE CONDITION THIS STUDY WILL HELP IN FINDING THE BEST OPTION FOR SPINAL ANAESTHESIA FOR DAYCARE GYNAECOLOGICAL SURGERIES WHICH WILL HELP IN FASTER RECOVERY AND EARLIER DISCHARGE WITH ADEQUATE SENSORY MOTOR BLOCK LESS TOXICITY AND STABLE HAEMODYNAMIC PARAMETERS |