Comparing Hyperbaric Levobupivacaine and Hyperbric Ropivacaine as spinal anesthetic drugs for elective lower limb orthopedic surgeries.

To Study and Compare The Effect and Block Characteristic Of Hyperbaric Levo- Bupivacaine Versus Hyperbaric Ropivacaine In Elective Lower Limb Orthopaedic Surgeries Under Spinal Anaesthesia in Sub Himalayan Population- A Prospective, Randomized, Triple-Blind Study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056435

Enrollment

Registered

2023-08-11

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: O- Medical and Surgical Health Condition 2: M971- Periprosthetic fracture around internal prosthetic knee joint

Interventions

Intervention1: Spinal anaesthesia is type a of neuraxial anaesthesia technique which involves placing local anaesthetic directly in the intrathecal space (subarachnoid space). The first regional anaes

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients with Body Mass Index (BMI) between 18 -29.9 kg/m2. 2)ASA I and II patients scheduled for elective lower limb orthopaedic surgery with anticipated duration of surgery between 120 - 180 mins

Exclusion criteria

Exclusion criteria: 1. Patients refusal for central neuraxial block. 2. Patients with BMI more than 30. 3. Patients allergic to the drugs under consideration. 4. Patients having absolute contraindication for spinal anaesthesia. 5. Primary or metastatic malignancy. 6. Patients with deformity of spine where drug spread is unpredictable. 7. Partial effect or failed spinal. 8. Patients in which space other than L3-L4 inter-vertebral space is used for instituting spinal.

Design outcomes

Primary

Measure	Time frame
efficacy of the two drugs hyperbaric Levo-bupivacaine & hyperbaric Ropivacaine in subarachnoid block in terms of sensory and motor block characteristics.Timepoint: time required for onset and regression of sensory and motor blockade. sensory and motor block at 20 minutes	—

Secondary

Measure	Time frame
Post operative haemodynamic parametersTimepoint: haemodynamic monitoring at 0,15,30,45,60,75,90,105,120,135,150,165,180,195,210,225,240 minutes;To study effect of drug on intra operative hemodynamic parameters of the patient, total vasopressor requirement between two groups & side effect of drug used if any.Timepoint: Hemodynamic parameters at 0, 3,6,9,12,15,20,25,30,35,40,45,50,55,60,65,70,75,80,85,90,95,100,105,110,115,120,125,130,135,140,145,150,155,160,165 minutes	—

Measure

Time frame

Post operative haemodynamic parametersTimepoint: haemodynamic monitoring at 0,15,30,45,60,75,90,105,120,135,150,165,180,195,210,225,240 minutes;To study effect of drug on intra operative hemodynamic parameters of the patient, total vasopressor requirement between two groups & side effect of drug used if any.Timepoint: Hemodynamic parameters at 0, 3,6,9,12,15,20,25,30,35,40,45,50,55,60,65,70,75,80,85,90,95,100,105,110,115,120,125,130,135,140,145,150,155,160,165 minutes

—

Countries

India

Contacts

Public ContactDr Dheeraj Singha

Dr, Rajendra Prasad Government Medical College

dheerajsinghaa@gmail.com8091048700

Outcome results

None listed

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