Comparision of two adjuvant opioid drugs fentanyl and nalbuphine used for spinal anaesthesia in lower limb surgeries

A comparative study to know the efficacy of intrathecal nalbuphine versus intrathecal fentanyl as an adjuvant to bupivacaine for lower limb surgeries

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033463

Enrollment

Registered

2021-05-07

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: M999- Biomechanical lesion, unspecified

Interventions

Intervention1: Intrathecal injection of Fentanyl AND Nalbuphine: To study the effects of intathecal hyperbaric bupivacaine 0.5% with fentanyl versus hyperbaric bupivacaine 0.5% with nalbuphine in low

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients aged between 18-60 years of both sex undergoing elective lower limb surgeries. Patients belonging to ASA Grade Ð? and Ð?Ð?.

Exclusion criteria

Exclusion criteria: Infection at the site of injection. Hypersensitivity to study drugs. Coagulopathy or other bleeding diathesis. Patients with peripheral neuropathy. Patients with cardiac, pulmonary, hepatic or renal disorder. Pregnancy.

Design outcomes

Primary

Measure	Time frame
To compare the onset and duration of sensory and motor blockade of fentanyl and nalbuphine adjuvant to bupivacaine.Timepoint: At 0, 5, 10, 15, 30, 60 and 120 minute and time of rescue analgesia.	—

Secondary

Measure	Time frame
To compare the haemodynamic changes like heart rate and blood pressure, Time of rescue analgesia and Side effects of study drugs. Timepoint: At 0, 5, 10, 15, 30, 60 and 120 minute and time of rescue analgesia.	—

Countries

India

Contacts

Public ContactSwathi N R

Shri B M Patil Medical College Hospital & Research Centre

drvijaykatti@gmail.com9844585900

Outcome results

None listed

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