Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-11-30

Brief Summary

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This is a multicenter, randomized, double-blind, active-controlled study to evaluate the non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in lower limbs vascular surgery.

The schedule consists of four visits: screening (visit 1); pre-anesthetic evaluation and randomization (visit 2); treatment (visit 3) and discharge from study (visit 4).

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Detailed Description

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Conditions

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Spinal Anesthesia Vascular Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Hyperbaric Novabupi® 0.5% (bupivacaine S75:R25 + 8% glucose)

Group Type EXPERIMENTAL

bupivacaine S75:R25 plus 8% glucose

Intervention Type DRUG

Spinal anesthesia, 20 mg

Hyperbaric Neocaine® 0.5% (bupivacaine S50:R50 + 8% glucose)

Group Type ACTIVE_COMPARATOR

bupivacaine S50:R50 plus 8% glucose

Intervention Type DRUG

Spinal anesthesia, 20 mg

Interventions

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bupivacaine S75:R25 plus 8% glucose

Spinal anesthesia, 20 mg

Intervention Type DRUG

bupivacaine S50:R50 plus 8% glucose

Spinal anesthesia, 20 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of written informed consent
* Both sexes
* Age between 18 and 80 years, inclusive
* ASA category I or II
* Indication of spinal anesthesia for varicose vein surgery in lower limbs with a maximum duration of 3 hours.

Exclusion Criteria

* Contraindications to spinal anesthesia
* Hypersensitivity or intolerance to local anesthetics or to the components of formula
* Use of any anticoagulant, regardless of type until 60 days before entering the study
* Spinal cord injuries, peripheral neuropathies or any other neurological conditions leading to sensory and / or motor disorders
* Dementia, mental retardation and other major cognitive changes
* Obesity with body mass index (BMI) \> 30 or difficulty in performing the puncture
* Anatomical difficulty in the spine in the opinion of the Investigator that can make puncture difficult
* Any previous surgical intervention of the spine
* Tattoo at the puncture site
* Participants with a history of alcohol or illicit drug abuse, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th edition
* Pernicious anemia
* History of severe anaphylactic reactions or Steven-Johnson disease
* Changes in safety exams (applicable at the time of randomization):

* International Normalized Ratio ≥ 1.4
* Hemoglobin \< 10 g / dL
* Platelet count \<100,000 / mm3
* Glycemia\> 200 mg / dL
* Bradyarrhythmias: heart block with clinical repercussion in the investigator's opinion
* Maximum of eight ventricular extrasystoles per minute, evident on the ECG
* Pregnancy or lactation
* Any other condition that, in the opinion of the Investigator, may lead to an increased risk for the participant.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No