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A study to evaluate of nalbuphine 5mg used as an adjuvant with or without 0.5% levobupivacaine for postoperative relief of pain in lower limb surgeries in epidural anaesthesia.

EVALUATION OF NALBUPHINE AS AN ADJUVANT TO LEVOBUPIVACAINE IN EPIDURAL ANAESTHESIA FOR LOWER LIMB ORTHOPAEDIC SURGERIES : A PROSPECTIVE RANDOMIZED PLACEBO CONTROLLED STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042907
Enrollment
60
Registered
2022-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: M160- Bilateral primary osteoarthritis of hip Health Condition 2: M170- Bilateral primary osteoarthritis of knee Health Condition 3: O- Medical and Surgical Health Condition 4: M236- Other spontaneous disruption of ligament(s) of knee Health Condition 5: M972- Periprosthetic fracture around internal prosthetic ankle joint Health Condition 6: M970- Periprosthetic fracture around internal prosthetic hip joint Health Condition 7: M971- Periprosthetic fracture around internal pro

Interventions

Intervention1: Epidural anaesthesia: Duration of analgesia is assessed Control Intervention1: 0.5% isobaric levobupivacaine with or without nalbuphine 5mg: Epidural anaesthesia using 0.5% LEVOBUPIVA

Sponsors

JLN medical college Ajmer
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient belonging to ASA class-I and II. Patient undergoing lower limb surgeries. Informed consent.

Exclusion criteria

Exclusion criteria: Age 65. ASA physical status III and above. Patient refusal. Patient with hypersensitivity or allergic tO levobupivacaine and nalbuphine. Patients on anticoagulants Infection at the site of lumbar puncture. Contraindication of epidural anaesthesia. Patient with preexisting peripheral neuropathy and neurological deficit.

Design outcomes

Primary

MeasureTime frame
Duration of analgesiaTimepoint: 1 year—

Secondary

MeasureTime frame
Onset and duration of sensory block. Onset and duration of motor block. Quality of analgesia. Visual analogue score . Hemodynamic changes if any. Adverse effects/ complication if any Timepoint: 1 year—

Countries

India

Contacts

Public ContactDr Deepak Kumar Garg

JLN medical college Ajmer

drdeepakgarg04@gmail.com9829399322

Outcome results

None listed

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