CTRI/2021/09/036980Not yet recruitingPhase 4
A comparative study of Nalbuphine and Fentanyl as adjuvant to Bupivacaine in spinal anesthesia in Lower limb orthopedic surgeries.
Mahatma gandhi medical college and hospital1 site in 1 country80 target enrollmentStarted: January 10, 2021Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 1)The characteristic of sensory and motor block
Study Overview
Brief Summary
we compare effect of fentanyl and nalbuphine as adjuvant to bupivacaine in spinal anaesthesia in lower limb orthopedic surgeries. we compare onset of sensory block , maximum dermatomal block height, onset of complete motor block.
we also compare time of first rescue analgesia , patient satisfaction.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients withASAclass1/2 lower limb surgeries patient giving written and informed consent.
Exclusion Criteria
- •Patient refusal patient with bledding diasthesis,allergic to study drug,neurological disease, spinal deformity, septicemia Patient with local infection at injection site.
Outcomes
Primary Outcomes
1)The characteristic of sensory and motor block
Time Frame: 1)watch for need of post-operative analgesia up to 24 hours | 2)Watch for regression of sensory block up to T10 for 135 min | 2)
2)Comparision of hemodynamic parameter and sedation score
Time Frame: 1)watch for need of post-operative analgesia up to 24 hours | 2)Watch for regression of sensory block up to T10 for 135 min | 2)
Secondary Outcomes
- 1)Time of first rescue analgesia(2) Patient satisfaction and adverse effect)
Investigators
Study Sites (1)
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