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A Study in 80 Pregnant Women Undergoing Planned Cesarean Section Comparing Two Spinal Anaesthesia Drugs Levobupivacaine and Bupivacaine for Safety and Effectiveness

Efficacy and safety of hyperbaric levobupivacaine vs. hyperbaric bupivacaine in spinal anaesthesia for caesarean section - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109244
Enrollment
80
Registered
2026-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Control Intervention1: Nil: Nil Control Intervention2: NIL: NIL

Sponsors

K S Hegde Medical Academy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Pregnant ladies aged above 18 years undergoing lower segment caeserean section under spinal anaesthesia using 25G Quincke Babcock needle 2.ASA physical status II 3.Singleton pregnancy 4.Height of 150 cm or more

Exclusion criteria

Exclusion criteria: 1.History of allergy to study drugs 2.Pregnant females with neurological deficits of lower extremities 3.Complicated pregnancy 4.Conversion of spinal to general anaesthesia intraoperatively 5.Duration more than 2hours

Design outcomes

Primary

MeasureTime frame
1.To compare the efficacy in terms of onset and duration of motor and sensory block in every 1 min until 5 min followed by every 5 min between the hyperbaric Levobupivacaine with Fentanyl versus hyperbaric Bupivacaine with Fentanyl in spinal anaesthesia for elective caesarean sections 2.To compare the safety in terms of hemodynamic profile of hyperbaric Levobupivacaine with Fentanyl versus hyperbaric Bupivacaine with Fentanyl in spinal anaesthesia for elective caesarean sectionsTimepoint: 1.To compare the efficacy in terms of onset and duration of motor and sensory block 1 min until 5 min followed by every 5 min between the hyperbaric Levobupivacaine with Fentanyl versus hyperbaric Bupivacaine with Fentanyl in spinal anaesthesia for elective caesarean sections 2.To compare the safety in terms of hemodynamic profile of hyperbaric Levobupivacaine with Fentanyl versus hyperbaric Bupivacaine with Fentanyl in spinal anaesthesia for elective caesarean sections

Secondary

MeasureTime frame
1.To compare the adverse effects during the surgery 2.To compare the APGAR scores of neonate born to mothers at 1 min after birth & 5 min after birth 3.To evaluate the time to first rescue analgesic administration within 24 hours postoperatively 4.To compare the satisfaction of operating surgeon immediately post surgeryTimepoint: 1.To compare the adverse effects during the surgery 2.To compare the APGAR scores of neonate born to mothers at 1 min after birth & 5 min after birth 3.To evaluate the time to first rescue analgesic administration within 24 hours postoperatively 4.To compare the satisfaction of operating surgeon immediately post surgery

Countries

India

Contacts

Public ContactDR RASHMI SOORI

K S HEGDE MEDICAL ACADEMY

drrashmisoori@gmail.com8050152374

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026