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A Study to compare the effect of nalbuphine and fentanyl as an additive to Hyperbaric bupivacaine in Spinal anaesthesia to compare intra-OT hemodynamic response

A COMPARATIVE STUDY BETWEEN INTRA-THECAL HYPERBARIC BUPIVACAINE 0.5% 3.0 cc WITH NALBUPHINE 0.4 MILLIGRAM VERSUS HYPERBARIC BUPIVACAINE 0.5% 3.0 CC WITH FENTANYL 25 MICROGRAM IN INFRAUMBILICAL SURGERIES

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076695
Enrollment
30
Registered
2024-11-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: 7- Osteopathic Health Condition 2: O- Medical and Surgical Health Condition 3: M161- Unilateral primary osteoarthritisof hip Health Condition 4: M872- Osteonecrosis due to previous trauma Health Condition 5: M800- Age-related osteoporosis with current pathological fracture Health Condition 6: M228- Other disorders of patella

Interventions

Intervention1: IN. FENTANYL 25 MCG INTRATHECALLY: INJ. FENTANYL 25 MCG INTRATHECALLY AS AN ADDITIVE TO INJ. BUPIVACAINE HYPERBARIC Control Intervention1: INJ. NALBUPHINE 0.4 MG INTRATHECALLY: INJ. N

Sponsors

Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients willing to sign the informed written consent. Patients of ASA Grade I and II of either gender. Under Spinal anaesthesia for elective BELOW UMBILICAL SURGERIES Aged 18 - 60 years. No known history of allergy, sensitivity to local anaesthetics of the amide group and other drugs used for this study.

Exclusion criteria

Exclusion criteria: Patient refusal. Patient not NIL by mouth. History of seizure disorder. Known allergy to trial drugs. Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction. ASA III, IV, V Patients. Patient with prior pre-existing Comorbidities (Heart diseases, Respiratory disease, Kidney diseases , known fetal abnormalities) Pregnant females Failed spinal anaesthesia converted to general anaesthesia Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities. Patients fulfilling above inclusion criteria are taken for study.

Design outcomes

Primary

MeasureTime frame
Aim of this study is to compare the efficacy of Fentanyl and nalbuphine used as additive to bupivacaine in subarachnoid block to compare hemodynamic response in infraumbilical surgeriesTimepoint: baseline 0 Minute 2 Minutes 5 Minutes 10 Minutes 20 Minutes 30 Minutes 45 Minutes 60 Minutes 75 Minutes 90 Minutes 120 Minutes 150 Minutes 180 Minutes—

Secondary

MeasureTime frame
to compare duration of Post-operative analgesia in group fentanyl and group nalbuphineTimepoint: post operative rescue anaglesia—

Countries

India

Contacts

Public ContactKartik H Sangam

Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre

sangam2494@gmail.com8767272524

Outcome results

None listed

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