CTRI/2022/04/041726CompletedNot Applicable
“Comparison of intrathecal hyperbaric Ropivacaine 0.75% and hyperbaric Bupivacaine 0.5% in lower limb orthopaedic surgery-A prospective randomised double blind comparative studyâ€
Department of Anaesthesiology1 site in 1 country80 target enrollmentStarted: April 15, 2022Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Duration of Analgesia
Study Overview
Brief Summary
Our original study is comparison of intrathecal 0.5 % bupivacaine heavy and 0.75% ropivacaine heavy for lower limb surgeries in terms of duration of analgesia, block characterstics. kindly consider our study for ctri registration.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with ASA physical status Grade I and II of either sex.
- •Patients in the age group of 18-60 years.
- •Posted for lower limb orthopedic surgeries under spinal anaesthesia.
Exclusion Criteria
- •Patients posted for emergency surgeries.
- •Pregnant patients.
- •Patients having coagulation abnormalities, platelet count <75,000, INR >1.5, or on anticoagulants.
- •Patients having systemic illness (severe hypovolemia, raised intracranial pressure, neuromuscular diseases, ischemic/ valvular/ congenital heart diseases, psychiatric, hematological disorder).
- •Patients having any absolute contraindications for spinal anesthesia.
- •Any allergy to study drugs or local anaesthetic drugs.
- •Short stature (height <150cms), with spinal deformity.
Outcomes
Primary Outcomes
Duration of Analgesia
Time Frame: 4 hours postoperatively
Secondary Outcomes
- onset and duration of sensory block, onset and duration of motor block and hemodynamic parameters.(Intraoperative (3-4 hours))
Investigators
Study Sites (1)
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