To Compare The Effect Of Premixed Versus Sequential Administration Of drugs In Spinal anesthesia For Lower Limb Surgeries

To Compare The Efficacy Of Premixed Versus Succedent Administration Of Fentanyl And Hyperbaric Bupivacaine In Subarachnoid Block For Lower Limb Surgeries: Double Blind Randomized Control Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056402

Enrollment

120

Registered

2023-08-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

Interventions

Intervention1: Fentanyl and 0.5%heavy bupivacaine: 0.5ml fentanyl first then 2.5ml 0.5% heavy bupivacaine for one year Control Intervention1: 0.5% heavy bupivacaine plus fentanyl: 2.5ml of 0.5% heavy

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to ASA physical status 1 and 2 Age 18-60years, belonging to either sex Patients giving informed written and valid consent Patients undergoing elective orthopedic lower limb surgeries under spinal anesthesia.

Exclusion criteria

Exclusion criteria: Patients having uncontrolled hypertension or diabetes mellitus Patients with renal and hepatic failure, cardiac block, arrhythmias, coagulopathy disorders and neurological disorders. Patients having hypersensitivity to any of the study drugs Patients with known contraindications to spinal anesthesia

Design outcomes

Primary

Measure	Time frame
To determine the efficacy of sequential administration of bupivacaine & fentanyl in providing early onset of aanesthesia & hemodynamic stabilityTimepoint: pinprick sensation for every 5min till 30mins & then every 15mins till completion motor status assesed immediately then every 5mins after injection until reaching highest sensory level & motor reaching to modified bromage scale zero blood pressure, heart rate & pulse oximetry performed every 5mins till 30mins and then every 15 mins till completion	—

Measure

Time frame

To determine the efficacy of sequential administration of bupivacaine & fentanyl in providing early onset of aanesthesia & hemodynamic stabilityTimepoint: pinprick sensation for every 5min till 30mins & then every 15mins till completion motor status assesed immediately then every 5mins after injection until reaching highest sensory level & motor reaching to modified bromage scale zero blood pressure, heart rate & pulse oximetry performed every 5mins till 30mins and then every 15 mins till completion

—

Secondary

Measure	Time frame
duration of sensory & motor blockade regression of modified bromage scale to zero Time for 1st rescue analgesia in post operative periodTimepoint: pinprick sensation for every 5min till 30mins & then every 15mins till completion motor status assesed immediately then every 5mins after injection until reaching highest sensory level & motor reaching to modified bromage scale zero severity of pain at 2,4,6,12 hrs after surgery measured by VAS score total doses of analgesics given for 24hrs post operatively will be noted	—

Measure

Time frame

duration of sensory & motor blockade regression of modified bromage scale to zero Time for 1st rescue analgesia in post operative periodTimepoint: pinprick sensation for every 5min till 30mins & then every 15mins till completion motor status assesed immediately then every 5mins after injection until reaching highest sensory level & motor reaching to modified bromage scale zero severity of pain at 2,4,6,12 hrs after surgery measured by VAS score total doses of analgesics given for 24hrs post operatively will be noted

—

Countries

India

Contacts

Public ContactDr Basavaraj kallapur

karnataka institute of medical sciences,hubli

doc_basu@yahoo.co.in9449834389

Outcome results

None listed

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