A comparison between the hyperbaric solutions of ropivacaine and levobupivacaine for spinal anaesthesia in lower limb orthopaedic surgeries

A comparative study between 0.75% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine for spinal anaesthesia in lower limb orthopaedic surgeries - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064415

Enrollment

Registered

2024-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: M966- Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate Health Condition 2: S720- Fracture of head and neck of femur Health Condition 3: S826- Fracture of lateral malleolus Health Condition 4: S724- Fracture of lower end of femur Health Condition 5: S823- Fracture of lower end of tibia Health Condition 6: S825- Fracture of medial malleolus Health Condition 7: S820- Fracture of patella Health Condition 8: S723- Fracture of shaft of fem

Interventions

Intervention1: 0.75% hyperbaric Ropivacaine: following lumbar puncture 3 ml (22.5 mg) of 0.75% hyperbaric ropivacaine will be injected intrathecally (in the sub-arachnoid space) for spinal anaesthesia

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia. 2. Age 18-60 years 3. ASA 1 and 2 4. All genders 5. Patients posted for surgeries with expected duration less than 3 hours

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. History of allergic reactions to Local Anaesthetics 3. Coagulopathy 4. History of neurological disorders 5. Severe cardio, respiratory, hepatic and renal disease 6. Patients with spinal deformity 7. Patients with previous spinal surgery

Design outcomes

Primary

Measure	Time frame
Aim- To compare the duration of analgesia between 0.75% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine for spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries Objective- 1. To compare the onset of sensory block in two drugs. 2. To compare the onset of motor block in two drugs. Timepoint: Onset and time taken for regression of sensory and motor block will be recorded after every 3 minutes for the first 15 minutes after injection then every 5 minutes for the next 25 minutes and at 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes. Duration of analgesia was assessed using Numerical Rating Scale at 2, 4, 6 and 12 hours in the post-operative period.	—

Measure

Time frame

Aim- To compare the duration of analgesia between 0.75% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine for spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries Objective- 1. To compare the onset of sensory block in two drugs. 2. To compare the onset of motor block in two drugs. Timepoint: Onset and time taken for regression of sensory and motor block will be recorded after every 3 minutes for the first 15 minutes after injection then every 5 minutes for the next 25 minutes and at 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes. Duration of analgesia was assessed using Numerical Rating Scale at 2, 4, 6 and 12 hours in the post-operative period.

—

Secondary

Measure	Time frame
1. To compare the effect of the two drugs on hemodynamic parameters. 2. To evaluate any adverse effects.Timepoint: Heart rate and Blood pressure will be monitored at every 5 minutes interval till 15 minutes followed by every 15 minutes interval till 90 minutes and then at every 30min interval.	—

Countries

India

Contacts

Public ContactDr Rajib Hazarika

Gauhati Medical College and Hospital

Rajibhazarika8@gmail.com9864063140

Outcome results

None listed

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