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Comparing two drugs used in spinal anaesthesia for lower limb orthopaedic surgery

Intrathecal fentanyl vs nalbuphine with bupivacaine in lower limb orthopaedic surgery: A prospective, randomized, single-blind study - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110075
Enrollment
130
Registered
2026-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: S899- Unspecified injury of lower leg

Interventions

Intervention1: Intrathecal Fentanyl with hyperbaric Bupivacaine: Single-dose intrathecal administration of 15 mg (3ml) 0.5% hyperbaric Bupivacaine with 25 mcg(0.5ml) fentanyl at the time of spinal ana

Sponsors

Fortis hospital Noida
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 65 yrs. 2. Patients scheduled for elective lower limb orthopaedic surgeries under spinal anaesthesia 3. ASA grade: I and II 4. Weight: 40 to 100 kgs 5. Either sex 6. Height: More than 150 cm.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The duration of spinal anaesthesia following intrathecal Nalbuphine and Fentanyl as adjuvant to 0.5% hyperbaric Bupivacaine in orthopaedic lower limb surgery.Timepoint: 0, 5mins, 10mins, 15 mins, 20 mins, 25 mins, 30 mins, 45 mins, 60 mins, 75 mins, 90 mins, 105 mins, 120 mins, 4 hrs, 6 hrs, 12 hrs, 24 hrs

Secondary

MeasureTime frame
Time of onset, maximum level, time to achieve maximum level and duration of sensory block.Timepoint: 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90,105,120,240,360,720,1440 minutes;Time of onset, intensity and duration of motor blockTimepoint: 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90,105,120,240,360,720,1440 minutes

Countries

India

Contacts

Public ContactAshish Roy

Fortis hospital, Noida

anutam.rai@fortishealthcare.com9810402906

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026