A Clinical study to compare the effect and safety of Levobupivacaine Hydrochloride in dextrose and Bupivacaine Hydrochloride in dextrose injection in Spinal Anaesthesia in Adult Patients.

Ã¢â?¬Å?A Prospective, Randomized, Double Blind, Multicentric, Two Arms, Phase III Clinical Trial To Assess The Efficacy And Safety Of Levobupivacaine In Dextrose Injection Manufactured By Neon Laboratories Ltd. Versus That Of Bupicain Heavy (Bupivacaine Hydrochloride In Dextrose Injection) Manufactured By Themis Medicare Ltd. For Spinal Anaesthesia in Adult PatientsÃ¢â?¬?.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/031638

Enrollment

236

Registered

2021-03-01

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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: Levobupivacaine (5mg/ml) in Dextrose (80mg/ml) Injection: A single dose of maximum up to 3 mL will be administered to the subject through intrathecal route at L3-L4 or L4-L5 interverteb

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients of age between 18 to 65 years (both inclusive). 2. ASA grade I and II will be included. 3. Surgeries on the lower limbs, pelvis and lower abdomen. 4. Patients willing to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe haemorrhage, severe hypotension or shock and arrhythmias, such as complete heart block, which severely restrict cardiac output 2. Patientswith contraindications for spinal anaesthesia. 3. Local infection at the site of proposed lumbar puncture. 4. Patients with any other clinically significant disorder or serious Systemic illness which needs treatment. 5. Patients with hypersensitivity to Bupivacaine, Levobupivacaine or to any local anaesthetic agent. 6. Female patientswho are pregnant or lactating. 7. Patientsreceiving monoamine oxidase inhibitors, Phenothiazines or tricyclic antidepressants within 14 days prior to participation in the trial.

Design outcomes

Primary

Measure	Time frame
1.Onset of anesthesia -time from the injection of spinal anaesthesia till achieving loss of pin prick sensation upto level T10. 2.Duration of anesthesia - time from the injection of spinal anaesthesia (either of the study drugs) till achieving restoration of sensation upto level T10. 3.Motor blockade will be assessed based on a Modified Bromage scale Timepoint: 24Ã?Â±6 Hours	—

Secondary

Measure	Time frame
1.Hemodynamic variables: Heart rate, blood pressure, RR and Spo2 will be recorded at Sb (Preoperative)and thereafter every 2 minutes for up to 10 minutes, then every 5 minutes until 30 minutes of spinal anaesthesia. The recordings will be taken every 30 minutes until the patient is transferred to the ward. 2.The assessment of safety will be based on the frequency of adverse events.Timepoint: 24Ã?Â±6 Hours	—

Measure

Time frame

1.Hemodynamic variables: Heart rate, blood pressure, RR and Spo2 will be recorded at Sb (Preoperative)and thereafter every 2 minutes for up to 10 minutes, then every 5 minutes until 30 minutes of spinal anaesthesia. The recordings will be taken every 30 minutes until the patient is transferred to the ward. 2.The assessment of safety will be based on the frequency of adverse events.Timepoint: 24Ã?Â±6 Hours

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Countries

India

Contacts

Public ContactDr Neeta Nargundkar

Neon Laboratories Ltd

neeta@pl.neongroup.com02268307000

Outcome results

None listed

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