Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery

Cristalia

Status and phase: Enrolling; Phase 3

Conditions: Spinal Anesthesia; Vascular Surgery

Treatments: Drug: bupivacaine S50:R50 plus 8% glucose; Drug: bupivacaine S75:R25 plus 8% glucose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03883763

CRT090

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

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

Experimental group

Treatment:

Drug: bupivacaine S75:R25 plus 8% glucose

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

Active Comparator group

Treatment:

Drug: bupivacaine S50:R50 plus 8% glucose