Clinical trial NCT03883763: Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery
Official title: Non-inferiority Study of Hyperbaric Novabupi® (Bupivacaine S75: R25) Compared to Hyperbaric Neocaine® (Bupivacaine S50: R50) in Spinal Anesthesia in Lower Limbs Vascular Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Spinal Anesthesia
Vascular Surgery
Lead sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison between arms from latency to T10 dermatome sensitive block
timeFrame: 20 minutes
measure: Comparison between arms from the duration of the sensory block
timeFrame: 24 hours
Secondary outcomes:
measure: Comparison between arms from the degree of motor blockage when blocking T10 sensitive
timeFrame: 20 minutes
measure: Comparison between arms from the duration of the motor block
timeFrame: 24 hours
measure: Comparison between arms from the highest level of sensory block
timeFrame: 3 hours
measure: Comparison between arms from the time to reach the highest level of sensory block
timeFrame: 1 hour
measure: Comparison between arms from the time for the 4-segment regression of the sensory block
timeFrame: 3 hours
measure: Comparison between arms of respiratory and cardiovascular safety
timeFrame: 12 hours
measure: Comparison between arms of cardiovascular safety
timeFrame: 24 hours
measure: Comparison between arms of cardiovascular safety
timeFrame: 12 hours
measure: Comparison between arms from the percentage of motor and sensory block failure
timeFrame: 20 minutes
measure: Comparison between arms from the occurrence of adverse events
timeFrame: 7 days
Other outcomes:
Locations:
city: São Luís
country: Brazil
facility: CEPEC
state: Maranhão
Study officials:
affiliation: HUUFMA - Hospital Universitário da Universidade Federal do Maranhão
name: João B Garcia, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: