CTRI/2023/03/051128Not yet recruitingNot Applicable
A prospective comparative study of efficacy of fentanyl versus buprenorphine as an additive to intrathecal hyperbaric bupivacaine in orthopaedic surgeries
Kallepally Sannidhi1 site in 1 country100 target enrollmentStarted: October 4, 2023Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Time to establish complete sensory and motor blockade
Study Overview
Brief Summary
Title: A prospective comparative study of efficacy of fentanyl versus buprenorphine as an additive to intrathecal hyperbaric bupivacaine in orthopaedic surgeries
Type of Study: A prospective single centre, observational study
Aim: To identify safer /more efficient adjuvant between fentanyl and buprenorphine
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patients between 20 – 60 years of age, undergoing elective lower limb orthopaedic surgeries with American society of Anaesthesiologists (ASA) physical status 1 and 2.
Exclusion Criteria
- •Patients with known allergy or hypersensitivity to local anaesthetic drugs Contraindications to regional or spinal anaesthesia BMI of less that 18.5 or more than 24.9 kg/m2 Patient not willing to give consent Emergencies, surgeries lasting >4 hours Patients in whom assessment of sensory and motor blockade is expected to be impossible/ unreliable.
Outcomes
Primary Outcomes
Time to establish complete sensory and motor blockade
Time Frame: Post spinal | 3 mins | 6 mins | 9 mins | 12 mins | 15 mins | 18 mins | 21 mins | Post surgery | 0 mins | 30 mins | 60 mins | 90 mins | 120 mins
Time for two segment regression and complete motor recovery
Time Frame: Post spinal | 3 mins | 6 mins | 9 mins | 12 mins | 15 mins | 18 mins | 21 mins | Post surgery | 0 mins | 30 mins | 60 mins | 90 mins | 120 mins
Secondary Outcomes
- Incidence of side effects- pruritis and urinary retention(Immediately in postop)
Investigators
Study Sites (1)
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