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Study of two different drug effect in spinal anesthesia

A comparative study of Nalbuphine and Fentanyl as adjuvant to Bupivacaine in spinal anesthesia in Lower limb orthopedic surgeries.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036980
Enrollment
80
Registered
2021-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: Z018- Encounter for other specified special examinations Health Condition 2: M972- Periprosthetic fracture around internal prosthetic ankle joint Health Condition 3: M970- Periprosthetic fracture around internal prosthetic hip joint Health Condition 4: M971- Periprosthetic fracture around internal prosthetic knee joint

Interventions

Control Intervention1: Nalbuphine as adjuvant to Bupivacaine.: 800 mcg Nalbuphine as adjuvant to 0.5% 3ml bupivacaine in intrathecal route for single time and observe the characteristic of block durin

Sponsors

Mahatma gandhi medical college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients withASAclass1/2 lower limb surgeries patient giving written and informed consent

Exclusion criteria

Exclusion criteria: Patient refusal patient with bledding diasthesis,allergic to study drug,neurological disease, spinal deformity, septicemia Patient with local infection at injection site

Design outcomes

Primary

MeasureTime frame
1)The characteristic of sensory and motor block 2)Comparision of hemodynamic parameter and sedation scoreTimepoint: 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

MeasureTime frame
1)Time of first rescue analgesia 2) Patient satisfaction and adverse effectTimepoint: up to 12 hours.

Countries

India

Contacts

Public ContactKhushbu Mukeshkumar Parekh

Mahatma gandhi medical college and hospital

drsudhirmgmch@gmail.com9829055666

Outcome results

None listed

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