| CTRI Number |
CTRI/2025/11/097224 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A study comparing two local anaesthetic drugs namely levobupivacaine and ropivacaine in patients of age group 18 to 60 years undergoing daycare surgeries of anal region under spinal anaesthesia to assess the duration of anaesthesia |
|
Scientific Title of Study
|
Comparative evaluation of intrathecal levobupivacaine and ropivacaine in patients undergoing daycare perianal 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 |
Shefalika Sharma |
| Designation |
Resident |
| Affiliation |
Dr DY Patil Medical College |
| Address |
Department of anaesthesia, 5th floor hi tech building Dr DY Patil Medical College, hospital and research centre, Sant Tukaram nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8600539127 |
| Fax |
|
| Email |
shefalika11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaya Suryawanshi |
| Designation |
Professor and HOD |
| Affiliation |
|
| Address |
Department of anaesthesia, 5th floor hi tech building, Dr DY Patil medical college, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chhaya Suryawanshi |
| Designation |
Professor and HOD |
| Affiliation |
Dr D. Y. Patil medical college, hospital and research centre |
| Address |
Department of anaesthesia, 5th floor hi tech building, Dr DY Patil medical college, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy, 5th floor Hitech building, Dr. DY Patil medical college, Pimpri, Pune 411018. Maharashtra. India |
|
|
Primary Sponsor
|
| Name |
Dr Shefalika Sharma |
| Address |
Dept of Anaesthesia, Dr. DY Patil medical college and hospital |
| Type of Sponsor |
Private medical college |
|
|
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 Shefalika Sharma |
Dr DY Patil medical college hospital and research centre |
Department of Anesthesia fifth floor high tech building Dr D Y Patil Medical College Hospital and Research Centre Sant Tukaram nagar Pimpri
Pune
MAHARASHTRA |
8600539127
shefalika11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics sub committee |
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 |
Levobupivacaine ropivacaine |
Levobupivacaine vs ropivacaine |
| Intervention |
Spinal anaesthesia |
Spinal anaesthesia will be given using one of the 2 drugs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade one and two patients
Patients undergoing perianal surgeries lasting one to one and a half hours
Haemodynamically stable patients
Patients who are not on any cardiac drugs
Availability of informed consent |
|
| ExclusionCriteria |
| Details |
ASA grade three or more
Patients posted for emergency procedures
Patients with major neurological, cardiac, respiratory, metabolic, renal, hepatic disease and coagulation disorders
Patient refusal
Surgeries lasting more than one and a half hours |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of the motor and sensory block between the two drugs |
immediately postop, 30mins, 1 hour, 2 hours, 3 hours, 4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of first rescue analgesia |
As per patient demand |
| Assess haemodynamic changes |
Immediately after subarachnoid block, 2 mins, 4mins, 6mins, 8mins, 10 mins, 15 mins, 20 mins, 25 mins, 30 mins, 35 mins, 40 mins, 50 mins, 60 mins, 70 mins, 80 mins |
| Time of ambulation |
When patient ambulates |
| Time of first void of urine |
Time of void of urine will be noted |
| Side effects of any drugs |
Noted only of patient shows any side effects post administration of the drug |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/12/2025 |
| 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="9"
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 is a prospective, randomised study to compare the anaesthetic efficacy of levobupivacaine and ropivacaine in spinal anaesthesia in patients undergoing daycare perianal surgeries
The parameters compared will be duration of motor block, duration of sensory block, time of first void of urine, time of ambulation and hemodynamic changes. |