Spinal Anaesthesia comparison with hyperbaric drug in lower limb surgeries

Comparison between hyperbaric levobupivacaine with buprenorphine and hyperbaric ropivacaine with buprenorphine for spinal anesthesia in patients undergoing lower limb surgery: A prospective randomised study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057689

Enrollment

Registered

2023-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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: Spinal anesthesia with hyperbaric 0.75% ropivacaine with buprenorphine 60mcg: Intrathecal administration of hyperbaric 0.75% ropivacaine with 60 mcg buprenorphine Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA I and II patients of either sex undergoing elective lower limb surgeries.2.Patients aged between 20 to 60 years

Exclusion criteria

Exclusion criteria: 1. Patients with bradycardia.(HR less than 50) 2. Patients with known hypersensitivity to local anaesthetic drugs. 3. Pregnant and lactating women 4.Contraindication to spinal anesthesia (Patient refusal, Coagulopathy, Local infection) 5. Patients diagnosed to have neurological diseases and Musculoskeletal diseases 6. Patients with previous spine surgeries and spine abnormalities.

Design outcomes

Primary

Measure	Time frame
To compare onset of sensory blockade between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine and 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeriesTimepoint: After giving spinal anesthesia	—

Secondary

Measure	Time frame
To compare duration of analgesia between intrathecal 0.5% (H) levobupivacaine with buprenorphine & 0.75% (H) ropivacaine with buprenorphine in lower limb surgeriesTimepoint: During & after surgery;To compare duration of sensory blockade between intrathecal 0.5% (H) Levobupivacaine with buprenorphine & 0.75% (H) Ropivacaine with buprenorphine in lower limb surgeriesTimepoint: During surgery;To compare hemodynamic changes between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeriesTimepoint: During & after surgery;To compare onset of motor blockade between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeriesTimepoint: After giving spinal anaesthesia;To compare side effects between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeriesTimepoint: After giving spinal anesthesia	—

Measure

Time frame

To compare duration of analgesia between intrathecal 0.5% (H) levobupivacaine with buprenorphine & 0.75% (H) ropivacaine with buprenorphine in lower limb surgeriesTimepoint: During & after surgery;To compare duration of sensory blockade between intrathecal 0.5% (H) Levobupivacaine with buprenorphine & 0.75% (H) Ropivacaine with buprenorphine in lower limb surgeriesTimepoint: During surgery;To compare hemodynamic changes between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeriesTimepoint: During & after surgery;To compare onset of motor blockade between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeriesTimepoint: After giving spinal anaesthesia;To compare side effects between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeriesTimepoint: After giving spinal anesthesia

—

Countries

India

Contacts

Public ContactDr NADIA ROSE

Rajarajeswari medical college and hospital

dr.nadia.rose@gmail.com9513454567

Outcome results

None listed

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