Effect of spinal anaesthesia of Injection Hyperbaric Bupivacaine mixed with Injection Fentanyl followed by Injection Isobaric Bupivacaine compared with Injection Hyperbaric Bupivacaine mixed with Injection Fentanyl in lower limb fractures in old age patients.

Efficacy of sequential intrathecal injection of Hyperbaric Bupivacaine-Fentanyl followed by Isobaric Bupivacaine compared with Hyperbaric Bupivacaine-Fentanyl in orthopaedic lower limb surgeries in geriatric patients: A prospective randomised double blind clinical study - No

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090420

Enrollment

Registered

2025-07-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Intervention1: Inj. Hyperbaric Bupivacaine with Inj. Fentanyl followed sequentially by Inj. Isobaric Bupivacaine: After pre-anesthetic evaluation, patients meeting the inclusion criteria will be selec

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age Group 65 to 99 year 2) Either Gender. 3) ASA II/III 4) Orthopaedic lower limb surgeries 5) Duration of surgery: 2.5 to 3 hours 6) Patients providing written informed consent

Exclusion criteria

Exclusion criteria: 1)Patient refusal. 2)Patients with Local skin infection, Vertebral column abnormalities, bleeding disorders, cardiopulmonary disease, neuropathies). 3)Patients with allergy to study drugs. 4)BMI more than 30kg/m2

Design outcomes

Primary

Measure	Time frame
To observe haemodynamic stability (blood pressure, pulse rate) and number of doses of Inj. Ephedrine (5mg) i.v. requiredTimepoint: Till 8 hours	—

Secondary

Measure	Time frame
To assess Sensory and Motor blockade characteristics like Onset of sensory block at L1 dermatomal level(mins) Time to achieve maximum sensory level (mins) Maximum sensory block achieved Time for two segment regression(mins) Total duration of sensory block (Time to regress till S1 dermatome) (mins) Onset of motor blockade (Modified Bromage 1) (mins) Time to achieve maximum motor blockade (mins) Duration of motor blockade (mins) To observe any complications like bradycardia, hypotension, respiratory depression, urinary retention, shivering.Timepoint: Till 24 hours	—

Measure

Time frame

To assess Sensory and Motor blockade characteristics like Onset of sensory block at L1 dermatomal level(mins) Time to achieve maximum sensory level (mins) Maximum sensory block achieved Time for two segment regression(mins) Total duration of sensory block (Time to regress till S1 dermatome) (mins) Onset of motor blockade (Modified Bromage 1) (mins) Time to achieve maximum motor blockade (mins) Duration of motor blockade (mins) To observe any complications like bradycardia, hypotension, respiratory depression, urinary retention, shivering.Timepoint: Till 24 hours

—

Countries

India

Contacts

Public ContactDr Kashmira Pander

Government Medical College,Baroda.

dr.kashmira13@gmail.com9099045151

Outcome results

None listed

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