Comparison of two hyperbaric drugs injection levobupivacaine and ropivacaine with injection fentanyl in spinal anaesthesia for surgeries below umbilicus.

A comparative study of hyperbaric levobupivacaine and hyperbaric ropivacaine with fentanyl for subarachnoid block in patients undergoing elective lower abdominal and lower limb surgeries. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060005

Enrollment

Registered

2023-11-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Health Condition 1: K402- Bilateral inguinal hernia, withoutobstruction or gangrene

Interventions

Intervention1: Comparative study of hyperbaric levobupivacaine and hyperbaric ropivacaine with fentanyl for subarachnoid block in patients undergoing elective lower abdominal and lower limb surgeries.

Eligibility

Inclusion criteria

Inclusion criteria: Age: 18-70 years. Height: 145-180 cm. weight:50-90 kg. Gender: both male and female. American Society of Anesthesiology (ASA) physical status class I and II. Patients posted for elective lower abdominal and lower limb surgeries.

Exclusion criteria

Exclusion criteria: 1.Patient not willing to give consent for participation in the study. 2. Age 70 years. 3. Height 180 cm. 4. Weight 90 kg. 5. ASA physical status class III and IV. 6.Patients with significant hepatic, cardiac, pulmonary, neurologic and psychiatric disease. 7. Hypersensitivity to local anaesthetics. 8. Any contraindication to spinal anaesthesia (local infection, spinal deformity,coagulopathy). 9. BMI > 35 kg/m2.

Design outcomes

Primary

Measure	Time frame
Onset of sensory block: using Pinprick. From intrathecal drug injection till to loss of pin prick sensation at L1 dermatome. Onset of motor block: From intrathecal drug injection till Modified Bromage scale 3. Duration of sensory block: From the time of onset till complete recovery of sensations. Duration of motor block: From the time of onset of motor block till return of motor block to modified Bromage scale 0. Hemodynamic parameters: Heart rate, systolic and diastolic blood pressure, oxygen saturation, respiratory rate.Timepoint: Both sensory and motor block: recorded at 1,3,5,10,15,20,25,30,45 and 60 minutes. Later every 30 minutes till complete block resolution. Hemodynamic parameters: Assessed at same times as sensory and motor block untill the 5th hour.	—

Measure

Time frame

Onset of sensory block: using Pinprick. From intrathecal drug injection till to loss of pin prick sensation at L1 dermatome. Onset of motor block: From intrathecal drug injection till Modified Bromage scale 3. Duration of sensory block: From the time of onset till complete recovery of sensations. Duration of motor block: From the time of onset of motor block till return of motor block to modified Bromage scale 0. Hemodynamic parameters: Heart rate, systolic and diastolic blood pressure, oxygen saturation, respiratory rate.Timepoint: Both sensory and motor block: recorded at 1,3,5,10,15,20,25,30,45 and 60 minutes. Later every 30 minutes till complete block resolution. Hemodynamic parameters: Assessed at same times as sensory and motor block untill the 5th hour.

—

Secondary

Measure	Time frame
Duration of Analgesia: From intrathecal drug injection till VAS score > 3. Incidence of side effects: recorded intraoperatively and postoperatively. Timepoint: Duration of Analgesia: VAS score. Assessed at 60 minutes after intrathecal drug injection, later every 30 minutes interval till 3 hours. side effects: Nausea, vomiting, pruritus, hypoxaemia, hypotension.	—

Countries

India

Contacts

Public ContactNeha Prabhakar Kamble

B.J.Government Medical College

nehakamble_84@yahoo.com9834192460

Outcome results

None listed

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