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Clinical Trials/CTRI/2024/10/075044
CTRI/2024/10/075044Not yet recruitingNot Applicable

A comparative study of hyperbaric levobupivacaine 0.5 percentage alone vs hyperbaric levobupivacaine 0.5 percentage with fentanyl in spinal anesthesia for lower abdominal and lower extremity surgeries

Dr Shantanu Yadav1 site in 1 country100 target enrollmentStarted: September 15, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Hyperbaric Levoupivacaine 0.5% with Fentanyl in

Study Overview

Brief Summary

The aim of the study is to compare and determine the effects of intrathecally

administered 0.5% hyperbaric levobupivacaine alone and 0.5% hyperbaric levobupivacaine with

fentanyl (25mcg) on reduction of higher blocks incidence simultaneously assess the onset,

duration of sensory and motor block, quality of subarachnoid block, hemodynamic stability,

perioperative analgesia and any adverse drug reactions in patients undergoing for Lower

Abdominal and Lower Extremity Surgeries.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patients aged 18 to 65 years scheduled for elective lower abdominal or lower extremity surgeries 2.American Society of Anaesthesiologists (ASA) physical status I or II.

Exclusion Criteria

  • 1.Hypersensitivity to Local Anaesthetics or Opioids 2.Cardiac dysfunction 3.Respiratory Disease 4.Coagulation Disorders 5.Pregnancy 6.Inability to Provide Informed Consent 7.ASA Physical Status III or higher.

Outcomes

Primary Outcomes

Hyperbaric Levoupivacaine 0.5% with Fentanyl in

Time Frame: Primary outcome assessed in 5 minutes

Spinal Anesthesia for Lower Abdominal & Lower

Time Frame: Primary outcome assessed in 5 minutes

Extremity Surgeries found to have longer

Time Frame: Primary outcome assessed in 5 minutes

duration of sensory and motor blockage then

Time Frame: Primary outcome assessed in 5 minutes

hyperbaric levobupivacaine 0.5% alone

Time Frame: Primary outcome assessed in 5 minutes

Secondary Outcomes

  • Quality of subarachnoid block, hemodynamic(stability,)

Investigators

Sponsor
Dr Shantanu Yadav
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Shantanu Yadav

Varun Arjun Medical College and Rohilkhand Hospital

Study Sites (1)

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