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Comparison of two drugs for regional anaesthesia for orthopaedic lower limb surgeries.

Comparison of Nalbuphine versus Fentanyl as an intrathecal adjuvant to hyperbaric Bupivacaine in orthopaedic lower limb surgeries

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011264
Enrollment
66
Registered
2018-01-11
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: null- Orthopaedic lower limb surgeries

Interventions

Intervention1: Intrathecal Nalbuphine with hyperbaric bupivacaine: 3 ml of 15 mg 0.5% hyperbaric bupivacaine with 0.5ml of 1mg nalbuphine injected intathecally. Control Intervention1: Intrathecal Fent

Sponsors

University College of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to American society of Anaesthesiology grade I and II. Patients with height more than 150cm and less than 180cm.

Exclusion criteria

Exclusion criteria: Patients with contraindications to central neuraxial block. Patients with height less than 150cm or weight more than 120kg. Patients with known allergy to the drugs involved in the study. Patients with history of chronic pain or long term opioid use. Patient refusal.

Design outcomes

Primary

MeasureTime frame
The duration of spinal analgesia following intrathecal Nalbuphine and Fentanyl as adjuvant to 0.5% hyperbaric bupivacaine in orthopaedic lower limb surgery.Timepoint: 0,0.5,1,1.5,2,3,4,8,12,24 hours

Secondary

MeasureTime frame
Time of onset, intensity and duration of motor block.Timepoint: 0,2,4,6,8,10,12,14,16,18,20,30,45,60,75,90,105,120,135,150,165,180 minutes;Time of onset, maximum level, time to achieve maximum level and duration of sensory block.Timepoint: 0,2,4,6,8,10,12,14,16,18,20,30,45,60,75,90,105,120,135,150,165,180 minutes

Countries

India

Contacts

Public ContactAnkit Sharma

University College of Medical Sciences

sujatac462@gmail.com9868399705

Outcome results

None listed

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