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Comparison of Two drug, hyperbaric Levobupivacaine with hyperbaric Bupivacaine for spinal anesthesia, and to find out the drug having better efficacy in Elective Orthopedic Joint Replacement Surgeries.

Comparison of efficacy of hyperbaric Levobupivacaine with hyperbaric Bupivacaine for spinal anesthesia in Elective Orthopedic Joint Replacement Surgeries. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/062165
Enrollment
110
Registered
2024-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: M171- Unilateral primary osteoarthritisof knee

Interventions

Intervention1: Spinal Anaesthesia with Hyperbaric Levobupivacaine: To determine duration of analgesia and note any adverse effects during intraoperative and postoperative period upto 5 hrs Control Int

Sponsors

Department of Anaesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Elective joint replacement surgery patients of age 40 to 65 years ASA Grade I and II. Enrolled for elective joint replacement surgeries

Exclusion criteria

Exclusion criteria: Patient refusal ASA Grade III or IV Age below 40 or above 65 years Infection at site of injection, any coagulopathy disorder or patients on anticoagulants, pre-existing neurological disease, psychological troubles, endocrinal disease Morbid obesity. Failure of spinal blockade. Uncontrolled Diabetes, Hypertension, Chronic kidney disease, Chronic liver disease Ischemic Heart Disease or other Cardiac illness Patients with previous spinal surgery, kyphoscoliosis or any spinal deformity Emergency surgeries. Patients with known history of previous allergy to local anesthetic drugs, especially drugs under investigations History of any neurological disease like Gullion-Burry syndrome, sub-acute combined degeneration of spinal cord etc.

Design outcomes

Primary

MeasureTime frame
compare the duration of sensory and motor blockade with Levobupivacaine vs Bupivacaine Timepoint: compare the duration of sensory and motor blockade with Levobupivacaine vs Bupivacaine at 0, 5, 15,30,45, 60, 120 mins

Secondary

MeasureTime frame
compare the ambulatory status of the patients of the two groupsTimepoint: Intraoperative and postoperative period;compare the hemodynamic changes between the two groupsTimepoint: Intraoperative and postoperative period;compare the incidence of systemic toxicity after intrathecal injection with respect to better or BupivacaineTimepoint: Intraoperative and postoperative period

Countries

India

Contacts

Public ContactProf Dr Anjan Das

College of Medicine and Sagore Dutta Hospital

anjan2k8@yahoo.com9874171440

Outcome results

None listed

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