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Comparison of drugs (Bupivacaine, Levobupivacaine and Ropivacaine)with added fentanyl used in spinal anesthesia for infraumbilical surgeries

A DBRCT comparing Hyperbaric solutions of Bupivacaine, Levobupivacaine and Ropivacaine with Fentanyl as a common additive in spinal anesthesia for infraumbilical surgeries - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056076
Enrollment
60
Registered
2023-08-03
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

Interventions

Intervention1: spinal anesthesia: drug given once at L3-L4 spinal level expected duration 2-6 hrs Control Intervention1: 0.5% bupivacaine with 25 mcg fentanyl : 0.5% bupivacaine with 25 mcg fentanyl

Sponsors

Ivy hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I and II patients posted for infraumbilical surgeries under spinal anesthesia

Exclusion criteria

Exclusion criteria: 1.ASA grade III and IV with severe systemic illness 2.Pregnancy 3.Patient with history of heart conduction abnormalities 4.Patient on alpha blockers 5.Any known hypersensitivity to the study drugs 6.Any contraindications to SA such as local infection, coagulopathy. 7.Patient with neurologic disorders ( with sensory or motor deficit )

Design outcomes

Primary

MeasureTime frame
1.Onset, duration and quality of sensory-motor block 2.Duration of post- operative analgesia Timepoint: at different time intervals after spinal anesthesia Baseline at 0 mins and then at 2 4 6 8 10 15 20 25 30 45 60 90 120 150 180 mins 210 mins 240 mins

Secondary

MeasureTime frame
1.Effect on hemodynamic 2.Any intra/post- operative complications related to spinal Anaesthesia 3.Any requirement to conversion of different type of anesthesia Timepoint: at different time intervals after spinal anesthesia Baseline at 0 mins & then at 2 4 6 8 10 15 20 25 30 45 60 90 120 150 180 mins

Countries

India

Contacts

Public ContactDr Mridul kumar

Ivy Health and Life Sciences Pvt Ltd ( Ivy hospital)

goel1399@gmail.com98888139971

Outcome results

None listed

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