A comparison of two types of spinal anesthesia medicines (levobupivacaine with fentanyl and bupivacaine with fentanyl) to see which works better and is safer for surgeries done on the lower part of the body, such as leg or foot operations

Comparative Evaluation of Levobupivacaine with Fentanyl versus Bupivacaine with Fentanyl in Lower Limb Surgeries under Spinal Anaesthesia - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/111630

Enrollment

Registered

2026-06-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: V988- Other specified transport accidents

Interventions

Intervention1: Intrathecal levobupivacaine with fentanyl: Spinal anaesthesia will be administered using intrathecal levobupivacaine with fentanyl at the L3 L4 or L4 L5 interspace under aseptic precaut

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients aged 18 to 60 years 2 ASA physical status I and II 3 Patients scheduled for elective lower limb surgeries 4 Patients who provide written informed consent

Exclusion criteria

Exclusion criteria: 1 Patient refusal to participate 2 Contraindications to spinal anaesthesia 3 Known allergy or hypersensitivity to amide local anaesthetics or fentanyl 4 Patients with neurological disorders or spinal deformities 5 Patients on chronic opioid therapy 6 Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Onset time of sensory block following intrathecal administration of the study drugs.Timepoint: Sensory block onset will be assessed every 2 minutes after intrathecal injection until achievement of T10 dermatome level, and recorded in minutes from time of drug administration.	—

Secondary

Measure	Time frame
Onset and duration of motor block, duration of postoperative analgesia, hemodynamic changes (heart rate and blood pressure), and incidence of adverse effects.Timepoint: Motor block will be assessed every 2 minutes after intrathecal injection until maximum block, then every 15 minutes until recovery. Hemodynamic parameters will be recorded at baseline, every 5 minutes for the first 30 minutes, then every 15 minutes intraoperatively and hourly for 6 hours postoperatively. Postoperative analgesia and adverse effects will be assessed up to 24 hours postoperatively.	—

Measure

Time frame

Onset and duration of motor block, duration of postoperative analgesia, hemodynamic changes (heart rate and blood pressure), and incidence of adverse effects.Timepoint: Motor block will be assessed every 2 minutes after intrathecal injection until maximum block, then every 15 minutes until recovery. Hemodynamic parameters will be recorded at baseline, every 5 minutes for the first 30 minutes, then every 15 minutes intraoperatively and hourly for 6 hours postoperatively. Postoperative analgesia and adverse effects will be assessed up to 24 hours postoperatively.

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Countries

India

Contacts

Public ContactDr Najwa K

Vinayaka Mission Kirupananda Variyar Medical College and Hospital

sabapathyv.appavoo@gmail.com9442566989

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026