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Comparison of Ropivacaine with Levobupivacaine for epidural analgesia in Lower limb orthopedic surgeries

To evaluate the efficacy of epidural analgesia with Ropivacaine 0.2% and levobupivacaine 0.25% in lower limb orthopaedic surgeries. - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069299
Enrollment
100
Registered
2024-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: M800- Age-related osteoporosis with current pathological fracture

Interventions

Intervention1: 0.2% Ropivacaine: 0.2 % Ropivacaine at 0.2 mg/kg/hr given epiduraly postoperatively Control Intervention1: 0.25% levobupivacaine: 0.25% Levobupivacaine epiduraly given postoperatively f

Sponsors

Samruddhi Dhamdhere
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA physical status 1 and 2 2. Written and informed consent given by patient. 3. Patient scheduled for eledtive lower limb orthopedic surgeries under combined spinal epidural anesthesia.

Exclusion criteria

Exclusion criteria: 1.Refusal for participation. 2.Known allergy or contraindication to the drugs used. 3.Cerebrovascular disease. 4.Intracranial hypertension

Design outcomes

Primary

MeasureTime frame
Reduction in the pain by epidural analgesia in lower limb orthopedic surgeries.Timepoint: T0: First test dose intraoperatively T60: 60 min after test dose T150: 150 min after test does T1: 1 hour postoperatively T2: 2 hours postoperatively T4: 4 hours postoperatively T8: 8 hours postoperatively T12: 12 hours postoperatively T16: 16 hours postoperatively T24: 24 hours postoperatively T36: 36 hour postoperatively T48: 48 hour postoperatively

Secondary

MeasureTime frame
1.Lower incidence of hypotension and bradycardia 2.Incidence of PONVTimepoint: T0: First test dose intraoperatively T60: 60 min after test dose T150: 150 min after test does T1: 1 hour postoperatively T2: 2 hours postoperatively T4: 4 hours postoperatively T8: 8 hours postoperatively T12: 12 hours postoperatively T16: 16 hours postoperatively T24: 24 hours postoperatively T36: 36 hour postoperatively T48: 48 hour postoperatively

Countries

India

Contacts

Public ContactDr Neha Panse

Smt Kashibai Navale Medical College and General Hospital, Pune

drnehaghule@gmail.com9689495891

Outcome results

None listed

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