CTRI/2025/11/097224Not yet recruitingPhase 4
Comparative evaluation of intrathecal levobupivacaine and ropivacaine in patients undergoing daycare perianal surgeries
Dr Shefalika Sharma1 site in 1 country70 target enrollmentStarted: December 22, 2025Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- To compare the duration of the motor and sensory block between the two drugs
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To compare the duration of the motor and sensory block between the two drugs
Time Frame: immediately postop, 30mins, 1 hour, 2 hours, 3 hours, 4 hours
Secondary Outcomes
- 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)
Investigators
Shefalika Sharma
Dr DY Patil Medical College
Study Sites (1)
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