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A Study to compare the effect of nalbuphine and fentanyl as an additive to Hyperbaric bupivacaine intrathecally to compare intra-OT hemodynamic response , Duration of Sensory and Motor onset, duration of Sensory and Motor blockade and Duration of analgesia

A COMPARATIVE STUDY BETWEEN INTRATHECAL HYPERBARIC BUPIVACAINE 0.5 percent 3.0cc WITH NALBUPHINE 0.4 MILLIGRAM VERSUS HYPERBARIC BUPIVACAINE 0.5 percent 3.0 CC WITH FETANYL 25 MICROGRAM IN INFRAUMBILICAL SURGERIES - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079600
Enrollment
60
Registered
2025-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: K353- Acute appendicitis with localizedperitonitis Health Condition 2: N289- Disorder of kidney and ureter, unspecified Health Condition 3: N350- Post-traumatic urethral stricture Health Condition 4: K409- Unilateral inguinal hernia, without obstruction or gangrene Health Condition 5: M173- Unilateral post-traumatic osteoarthritis of knee

Interventions

Intervention1: INJ. FENTANYL 25 MCG INTRATHECALLY: INJ. FENTANYL 25 MCG INTRATHECALLY AS AN ADDITIVE TO INJ. BUPIVACAINE HYPERBARIC 3.0cc Dose - 25mcg (0.5cc) Route - intrathecally Duration - Till a

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: Patients are 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 Age 20 - 60 years. No known history of allergy or 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. Patients with prior pre-existing Comorbidities (Heart diseases, Respiratory diseases, 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 the above inclusion criteria are taken for study.

Design outcomes

Primary

MeasureTime frame
This study aims to compare the efficacy of Fentanyl and nalbuphine used as an additive to bupivacaine in subarachnoid block to compare the hemodynamic response in infra-umbilical surgeriesTimepoint: Hemodynamic response and Onset of Sensory and motor blockade asseses at Baseline 2min 5 mins 10 mins 15 mins 20 mins 30 mins 45 mins 60 mins 90 mins 120 mins—

Secondary

MeasureTime frame
to compare duration of Post-operative analgesia in group fentanyl & group nalbuphineTimepoint: Post-operative Anaglesia Baseline Vas Score At 4 hours 6 hours 8 hours 12 hours—

Countries

India

Contacts

Public ContactDr Nilesh Shah

Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre

nileshshah730@gmail.com9825038233

Outcome results

None listed

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