Comparison of two drugs nalbuphine and fentanyl as an additive to 0.5% hyperbaric bupivacaine in lower abdominal surgeries

A prospective randomized comparative study of intrathecal Nalbuphine vs Fentanyl as an adjuvant to 0.5% Hyperbaric Bupivacaine in below umbilical surgeries

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056742

Enrollment

120

Registered

2023-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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: COMPARATIVE STUDY OF INTRATHECAL NALBUPHINE VS INTRATHECAL FENTANYL AS AN ADJUVANT TO 0.5 % HYPERBARIC BUPIVACAINE IN INFRA UMBILICAL SURGERIES: NACIPHINE, NEON LAB (NALBUPHINE) Vs VERF

Eligibility

Inclusion criteria

Inclusion criteria: patients posted for elective infra-umbilical surgerY under ASA physical status 1 & 2.

Exclusion criteria

Exclusion criteria: 1. Body Mass Index >30. 2. Patients with local site infection, allergy to the drugs that are tested or any other contraindications for spinal anesthesia. 3. Patients who cannot lie down/ non co-operative/ psychiatric illness. 4. Alcoholics. 5. Pregnant / Lactating women. 6. Patient having failed spinal, transformed into general anesthesia will be excluded from study. 7. Patients refusal for participation in the study. 8. Patients with height less than 150 cm.

Design outcomes

Primary

Measure	Time frame
To assess and compare the duration of post operative analgesia of Nalbuphine and Fentanyl as an adjuvant to 0.5 % Hyperbaric bupivacaine as intrathecal anesthesia in infra-umbilical surgeries.Timepoint: Duration of post operative analgesia assessed for every 30 minutes for 4hours	—

Secondary

Measure	Time frame
To assess and compare the onset and duration of sensory blockade and motor blockade. To assess and compare the hemodynamic parameters. To observe and compare the incidence of adverse events. Timepoint: 18 months	—

Countries

India

Contacts

Public ContactSri Priyadharshini B R

Sri Manakula Vinayagar Medical College and Hospital

lazarus.suneeth@gmail.com9500288659

Outcome results

None listed

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