Comparison Of Hyperbaric Levobupivacaine 0.5% with Hyperbaric Levobupivacaine 0.5% plus Fentanyl for Spinal anesthesia to Evaluate Sensory and Motor blockade duration in participants undergoing Infraumbilical surgery

A Comparative study of Hyperbaric Levobupivacaine 0.5 percent with Hyperbaric Levobupivacaine 0.5 percent plus Fentanyl on Sensory and Motor characteristics for Spinal Anaesthesia in Infra Umbilical surgery - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078332

Enrollment

Registered

2024-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: - Health Condition 2: K41- Femoral hernia

Interventions

Intervention1: Intrathecal Hyperbaric Levobupivacaine 0.5% heavy: Patients will receive 0.5% Hyperbaric Levobupivacaine 3ml(15mg) plus 1ml 0.9% normal saline once intrathecally over 15-20 seconds Cont

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of age group 18-60 years undergoing infraumbilical surgeries under subarchnoid block except LSCS 2.Patients willing to give written informed consent 3.Patients belonging to ASA I and II 4.Patient with height in the range of 150 cm to 175 cm

Exclusion criteria

Exclusion criteria: 1. Patients with history of hypersensitivity to local anesthetics. 2.Subjects having any absolute contraindications for spinal anaesthesia like increased ICP, severe hypovolemia , bleeding diathesis , local site infection, neurological deficit, spinal deformity. 3. Patients with neurological or psychiatric disorders or with communication problems. 4.Patients on antihypertensive medications. 5.ASA 3/4/5 6.Pregnant women undergoing LSCS

Design outcomes

Primary

Measure	Time frame
Onset of sensory block, time for maximum sensory blockade, two segment sensory regression, duration of sensory block,onset of motor blockade, maximum motor block, duration of motor block, duration of analgesia.Timepoint: Sensory blockade will be tested every 30 seconds from time of injection of drug till the loss of sensation at T10 dermatomal level and thereafter at 2 mins intervals till the maximum level of sensory blockade is achieved and subsequently at 30 mins interval until complete recovery. Motor block will be assessed every 1 minute for the first 5 min, then at 5-min intervals for next 30 minutes and at every 30 minutes intervals until complete resolution of motor anesthesia.	—

Measure

Time frame

Onset of sensory block, time for maximum sensory blockade, two segment sensory regression, duration of sensory block,onset of motor blockade, maximum motor block, duration of motor block, duration of analgesia.Timepoint: Sensory blockade will be tested every 30 seconds from time of injection of drug till the loss of sensation at T10 dermatomal level and thereafter at 2 mins intervals till the maximum level of sensory blockade is achieved and subsequently at 30 mins interval until complete recovery. Motor block will be assessed every 1 minute for the first 5 min, then at 5-min intervals for next 30 minutes and at every 30 minutes intervals until complete resolution of motor anesthesia.

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Secondary

Measure	Time frame
Hemodynamic parameters Blood pressure, changes in heart rateTimepoint: After injection of drug every 1 Minute interval for first 3 consecutive minutes followed by 5 minute intervals for the next 15minutes And at 15 minute intervals till the end of the surgery.	—

Countries

India

Contacts

Public ContactMAHAMAD JAVEEDULLA BAIG

Bangalore medical College and research institute

Javidbeig@gmail.com9886444173

Outcome results

None listed

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