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A prospective randomized study to compare the effect of fractionated versus bolus dose of Injection 0.5% bupivacaine and fentanyl in spinal anaesthesia for lower extremities orthopaedic surgery

A PROSPECTIVE RANDOMIZED STUDY TO COMPARE THE EFFECT OF FRACTIONATED VERSUS BOLUS DOSE OF INJECTION 0.5% BUPIVACAINE AND FENTANYL IN SPINAL ANAESTHESIA FOR LOWER EXTREMITIES ORTHOPAEDIC SURGERY. - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088558
Enrollment
90
Registered
2025-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: S723- Fracture of shaft of femur Health Condition 2: S729- Unspecified fracture of femur Health Condition 3: S823- Fracture of lower end of tibia Health Condition 4: S822- Fracture of shaft of tibia

Interventions

Intervention1: Fractionated dose of injection 0.5% hyperbaric bupivacaine with 25 mcg fentanyl in spinal anaesthesia for lower limb surgeries: Fractionated dose group will receive intially 2/3rd of to

Sponsors

Dr Ashwini solanki
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients undergoing lower limb surgeries. Age between 18 to 60 years ,ASA grade I and II

Exclusion criteria

Exclusion criteria: Age less than 18 years of age and more than 60 years Patient refusal ASA III & IV Infection at the site of injection Patient having hereditary coagulopathy, raised ICT, severely altered mental status, spinal deformities, aortic stenosis, BMI more than 35 kg/m2 and thromboprophylaxis, allergy to spinal anaesthesia

Design outcomes

Primary

MeasureTime frame
Expected early onset of sensory and motor blockage and prolonged duration of analgesia and more hemodynamic stability in fractionated dose groupTimepoint: 24 Hours

Secondary

MeasureTime frame
Expected better post operative analgesia and lesser side-effectsTimepoint: 24 Hours

Countries

India

Contacts

Public ContactDr Neelima tandon

Gajra Raja Medical College

dr.neelimatandon21@gmail.com9826215586

Outcome results

None listed

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