To study the efficacy of two spinal drugs premixed versus sequential administration in spinal anaesthesia in lower limb surgeries

A prospective randomized clinical study of efficacy of premixed versus sequential administration of fentanyl as an adjuvant to intrathecal hyperbaric bupivacaine in lower limb surgeries

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/06/034210

Enrollment

Registered

2021-06-14

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: Intrathecal injection of fentanyl and bupivacaine: To study the efficacy of premixed versus sequential administration of fentanyl as an adjuvant to intrathecal hyperbaric bupivacaine in

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 15-60 years of both sex undergoing elective lower limb surgeries under spinal anaesthesia. patients belonging to ASA grade 1 and 2.

Exclusion criteria

Exclusion criteria: Infection at the site of injection Hypersensitivity to study drugs Coagulopathy or other bleeding diathesis Patients with peripheral neuropathy Pregnancy Patients refusal

Design outcomes

Secondary

Measure	Time frame
To compare the hemodynamic changes like Heart rate and blood pressure, time of rescue analgesia and side effects of study drugsTimepoint: At 0, 5, 10, 15, 30, 60 and 120 minute and time of rescue analgesia	—

Primary

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

Countries

India

Contacts

Public ContactNirmaladevi K

Shri B M Patil Medical College Hospital & Research Centre

nirmalakagalkar77@gmail.com8217618954

Outcome results

None listed

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