A CLINICAL TRIAL TO STUDY THE EFFECTS OF TWO DRUGS, BUPIVACAINE AND LEVOBUPIVACAINE IN GYNAECOLOGICAL PATIENTS UNDERGOING SPINAL ANAESTHESIA

COMPARISON BETWEEN HYPERBARIC LEVOBUPIVACAINE AND HYPERBARIC BUPIVACAINE IN SUBARACHNOID BLOCK FOR ELECTIVE GYNAECOLOGICAL SURGERIES

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055667

Enrollment

142

Registered

2023-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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 Health Condition 2: N858- Other specified noninflammatory disorders of uterus

Interventions

Intervention1: Hyperbaric levobupivacaine: Dose: 13.5 mg with fentanyl 25 mcg Frequency: once at the start of surgery Route: intrathecal Duration: till patient recovers from the effect of drug Con

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to ASA I and II

Exclusion criteria

Exclusion criteria: Patients with significant cardiac,pulmonary, hepatic or renal disease Spinal deformities Abnormal coagulation profile (INR 1.5) Evidences of skin infections at the site of injection Disabling neuropsychiatric disorders Known hypersensitivity to bupivacaine, levobupivacaine or fentanyl Chronic drug abusers Alcoholics

Design outcomes

Primary

Measure	Time frame
To measure the onset of sensory block in both groups To measure the duration of sensory block in both groups To measure highest level of sensory block in both groups To measure the onset of motor block in both groups To measure the duration of motor block in both groups To find out the changes in heart rate & mean arterial blood pressure during the course of spinal anaesthesiaTimepoint: Every three minutes interval	—

Measure

Time frame

To measure the onset of sensory block in both groups To measure the duration of sensory block in both groups To measure highest level of sensory block in both groups To measure the onset of motor block in both groups To measure the duration of motor block in both groups To find out the changes in heart rate & mean arterial blood pressure during the course of spinal anaesthesiaTimepoint: Every three minutes interval

—

Secondary

Measure	Time frame
To compare if hyperbaric levobupivacaine is a safer alternative to hyperbaric bupivacaine for elective gynaecological surgeries in subarachnoid blockTimepoint: After completion of surgery, wearing of effects of spinal anaesthesia	—

Countries

India

Contacts

Public ContactDr Amit Kumar Ray

Institute of Post Graduate Medical Education and Research

raymit2005@gmail.com9830374904

Outcome results

None listed

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