To Compare the effect of heavy Ropivacaine with fentanyl versus the effect of heavy bupivaicaine with fentanyl for spinal block in patients undergoing surgeries below the belly button.

SAFETY AND EFFICACY OF HYPERBARIC ROPIVACINE WITH FENTANYL VS HYPERBARIC BUPIVACAINE WITH FENTANYL IN INFRAUMBILICAL SURGERIES : A PROSPECTIVE RANDOMIZED CLINICAL STUDY - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097633

Enrollment

128

Registered

2025-11-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: Hyperbaric Ropivacaine 0.75% 22.5mg with Fentanyl Citrate 20 mcg: Route : Intrathecal Dose : 22.5mg Ropivacaine + 20mcg Fentanyl Duration : over 10 seconds Control Intervention1: Hyperb

Eligibility

Inclusion criteria

Inclusion criteria: Age of 18 to 65 years ASA Grade I and II Patients undergoing various infra-umbilical surgeries under spinal anaesthesia

Exclusion criteria

Exclusion criteria: Refusal of spinal anaesthesia Coagulopathies Head injury and raised ICP Psychiatric diseases Known allergy to test drug Infection at site of injection Uncorrected Hypovolemia Fixed cardiac output states Pregnant patients

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of Ropivacaine with fentanyl and bupivacaine with fentanyl based on onset and duration of motor blockage Timepoint: base-line , before administration of spinal drug , 2min ,4mins,6 mins,8mins,10min,12mins,14mins,16mins,20mins ,30mins,then hourly till end of surgery , post op upto 4 hours	—

Secondary

Measure	Time frame
To compare and assess in the two groups: 1) Onset and duration of sensory blockage 2) Hemodynamic stability 3) Adverse effects if anyTimepoint: base-line , before administration of spinal drug , 2min ,4mins,6 mins,8mins,10min,12mins,14mins,16mins,20mins ,30mins,then hourly till end of surgery , post op upto 4 hours	—

Countries

India

Contacts

Public ContactDr Sunanda Panigrahi

Dr D Y Patil School Of Medicine

drnmishra1@gmail.com9820637093

Outcome results

None listed

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