A clinical trial to compare the effects of two drugs, ropivacaine and levobupivacaine in patients undergoing cesarean section under spinal anaesthesia

A comparitive evaluation of hemodynamic effects between hyperbaric Ropivacaine and hyperbaric Levobupivacaine in elective LSCS under spinal anaesthesia; a one year randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/058070

Enrollment

150

Registered

2023-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: Spinal anaesthesia with hyperbaric ropivacaine: Spinal anesthesia has been a popular method of anaesthesia for short, lower abdominal surgeries. Hyperbaric racemic bupivacaine is common

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I and II. Age between 20 to 40 years. Weight ranging from 70-90kg Height ranging from 155-185cm (5ft to 6ft) Patients undergoing elective LSCS under spinal anesthesia Provides Consent

Exclusion criteria

Exclusion criteria: Patient undergoing emergency surgery. Patient who are unable to give consent. Patient with obstetric complications Patient with suspected fetal compromise Coagulopathy Patients who do not fulfill inclusion criteria.

Design outcomes

Primary

Measure	Time frame
To compare hyperbaric ropivacaine to hyperbaric levobupivacaine with respect to hemodynamic responses’; blood pressure, heart rate and mean arterial pressure in elective LSCS cases.Timepoint: 2,4,6,8,10,15,30,45,60,90 minutes.	—

Secondary

Measure	Time frame
To compare the efficacy of spinal anaesthesia with respect to onset, duration and level of block with hyperbaric ropivacaine and hyperbaric Levobupivacaine in elective LSCS cases.Timepoint: The assessments of sensory block to pinprick will be performed at 2, 4, 6, 8, 10, and 15 min after the intrathecal injection. Motor block in the lower limb will be assessed by using a modified Bromage scale (0: no paralysis, 1: unable to raise extended leg, 2: unable to flex knee, 3: unable to flex ankle). These assessments will be performed immediately after the assessments of sensory block until the return of normal motor function.	—

Measure

Time frame

To compare the efficacy of spinal anaesthesia with respect to onset, duration and level of block with hyperbaric ropivacaine and hyperbaric Levobupivacaine in elective LSCS cases.Timepoint: The assessments of sensory block to pinprick will be performed at 2, 4, 6, 8, 10, and 15 min after the intrathecal injection. Motor block in the lower limb will be assessed by using a modified Bromage scale (0: no paralysis, 1: unable to raise extended leg, 2: unable to flex knee, 3: unable to flex ankle). These assessments will be performed immediately after the assessments of sensory block until the return of normal motor function.

—

Countries

India

Contacts

Public ContactNiyaz Abdul Salam

Jawaharlal Nehru Medical College, Belagavi

kedareshvara@gmail.com9886375154

Outcome results

None listed

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