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COMPARISON OF TWO DOSES OF OF A PAIN KILLER (NALBUPHINE) AS AN ADDITIVE TO LOCAL ANESTHETIC IN SPINAL ANESTHESIA.

COMPARISON OF 0.4 MG VERSUS 0.6 MG INTRATHECAL NALBUPHINE AS AN ADJUVANT TO HYPERBARIC BUPIVACAINE 0.5% IN LOWER ABDOMEN AND LOWER LIMB SURGERIES

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017240
Enrollment
120
Registered
2019-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Interventions

Intervention1: Group A: This group of patients will receive 0.4 mg of Nalbuphine as an adjuvant to 3 ml of 0.5% Bupivacaine plus 0.2 ml of normal saline intrathecally Control Intervention1: Group B:

Sponsors

SRI VENKATESHWAARA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All ASA 1 and 2 patients undergoing elective lower abdominal and lower limb surgeries under spinal anaesthesia

Exclusion criteria

Exclusion criteria: Infection at the site of injection ASA 3 and 4 Patients Hypersensitivity to Local Anaesthetics Increased intracranial pressure Coagulation disorders and other bleeding diathesis Pregnant Patients Patient with Infection at the site of injection ASA 3 and 4 Patients Hypersensitivity to Local Anaesthetics Increased intracranial pressure Coagulation disorders and other bleeding diathesis Pregnant Patients Patient with poorly controlled hypertension Patients with spine abnormalities and demyelinating lesions Patients with psychiatric illnesses Patients with significant hypotension, severe aortic/mitral stenosis Uncooperative Patients

Design outcomes

Primary

MeasureTime frame
Onset and duration of Motor and sensory BlockadeTimepoint: Duration of sensory Blockade assessed every hourly until the first rescue analgesia is required. Duration of motor blockade assessed by modified Bromage scale , assessed till the patient will be able to perform partial knee bend(modified bromage 6)

Secondary

MeasureTime frame
Nausea, vomiting, pruritusTimepoint: if any will be taken into record for the first 24 hours

Countries

India

Contacts

Public ContactRaghuraman M S

SRI VENKATESHWAARA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE

drraghuram70@gmail.com9486837256

Outcome results

None listed

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