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A prospective study to compare efficacy of fentanyl versus buprenorphine as an adjuvant to local anaesthetic hyperbaric bupivacaine given in spinal anaesthesia in orthopaedic surgeries

A prospective comparative study of efficacy of fentanyl versus buprenorphine as an additive to intrathecal hyperbaric bupivacaine in orthopaedic surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/03/051128
Enrollment
100
Registered
2023-03-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

None listed

Sponsors

Kallepally Sannidhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients between 20 â?? 60 years of age, undergoing elective lower limb orthopaedic surgeries with American society of Anaesthesiologists (ASA) physical status 1 and 2

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Time to establish complete sensory and motor blockade Time for two segment regression and complete motor recoveryTimepoint: 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

MeasureTime frame
Incidence of side effects- pruritis and urinary retentionTimepoint: Immediately in postop

Countries

India

Contacts

Public ContactDr Arun Kumar H D

Department of Anaesthesiology, Kasturba medical college

arunhd2000@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026