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Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03883763
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Cristália Produtos Químicos Farmacêuticos Ltda.

Study Description
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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).


Condition or disease Intervention/treatment Phase
Spinal Anesthesia Vascular Surgery Drug: bupivacaine S75:R25 plus 8% glucose Drug: bupivacaine S50:R50 plus 8% glucose Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hyperbaric Novabupi® 0.5% (bupivacaine S75:R25 + 8% glucose) Drug: bupivacaine S75:R25 plus 8% glucose
Spinal anesthesia, 20 mg
Active Comparator: Hyperbaric Neocaine® 0.5% (bupivacaine S50:R50 + 8% glucose) Drug: bupivacaine S50:R50 plus 8% glucose
Spinal anesthesia, 20 mg


Outcome Measures
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Primary Outcome Measures :
  1. Comparison between arms from latency to T10 dermatome sensitive block [ Time Frame: 20 minutes ]
    Time elapsed between the withdrawal of the needle at the end of the injection of the local anesthetic and the absence of response to sensorial stimuli in the region corresponding to the T10 dermatome

  2. Comparison between arms from the duration of the sensory block [ Time Frame: 24 hours ]
    Time elapsed between the withdrawal of the needle at the end of the local anesthetic injection and the presence of positive sensitivity by needle stimulation in the L5 dermatome


Secondary Outcome Measures :
  1. Comparison between arms from the degree of motor blockage when blocking T10 sensitive [ Time Frame: 20 minutes ]

    The motor block will be evaluated by the modified Bromage scale. The degree of motor block will be assessed when the sensory block reaches T10.

    The motor block will be evaluated every 5 minutes from the end of the anesthetic injection (time 0) through the modified Bromage scale:

    • 0 = without motor block,
    • 1 = blocked hip,
    • 2 = blocked hip and knee,
    • 3 = blocked hip, knee and ankle.

    Will be recorded:

    • the degree of motor blockage when the sensory block reaches T10,
    • the time to reach the maximum block,
    • time for full recovery (Bromage score 0).

  2. Comparison between arms from the duration of the motor block [ Time Frame: 24 hours ]
    Duration of motor block will be considered as the time interval between needle withdrawal after puncture and return to score 0 on the modified Bromage scale. Time will be recorded to reach grade 3 motor block and at the end of surgery. During anesthesia recovery, evaluations will be performed every 15 minutes

  3. Comparison between arms from the highest level of sensory block [ Time Frame: 3 hours ]
  4. Comparison between arms from the time to reach the highest level of sensory block [ Time Frame: 1 hour ]
  5. Comparison between arms from the time for the 4-segment regression of the sensory block [ Time Frame: 3 hours ]
    The height of the sensitive block will be evaluated every 5 minutes until the maximum level is reached. From this point, the height of the block will be evaluated every 10 minutes until the regression of 4 levels

  6. Comparison between arms of respiratory and cardiovascular safety [ Time Frame: 12 hours ]

    Evidenced by the incidence, severity and causality of clinically significant SpO2 changes.

    Every 5 minutes SpO2 will be recorded until completing 60 minutes, every 10 minutes until completing 120 minutes, every 20 minutes until 12 hours.


  7. Comparison between arms of cardiovascular safety [ Time Frame: 24 hours ]

    Evidenced by the incidence, severity and causality of clinically significant changes in blood pressure measured automatically by cardiac monitoring.

    Every 5 minutes blood pressure will be recorded until completing 60 minutes, every 10 minutes until completing 120 minutes, every 20 minutes until completing 180 minutes and every 30 minutes until complete recovery of the motor function.


  8. Comparison between arms of cardiovascular safety [ Time Frame: 12 hours ]

    Evidenced by the incidence, severity and causality of clinically significant changes in heart rate measured automatically by cardiac monitoring.

    Every 5 minutes heart rate will be recorded until completing 60 minutes, every 10 minutes until completing 120 minutes, every 20 minutes until completing 180 minutes and every 30 minutes until complete recovery of the motor function


  9. Comparison between arms from the percentage of motor and sensory block failure [ Time Frame: 20 minutes ]

    After the needle has been withdrawn, the anesthetic should be installed for up to 20 minutes. If no sensory and / or motor blockage is observed after this period, the Investigator will indicate that there was an anesthetic failure that should be classified as:

    A. total block failure (absence of anesthesia in sensory and motor aspects with preserved sensitivity of the perineal region) B. partial failure (when any area below the T10 dermatome shows signs of analgesia or motor block, but surgery can not be performed, requiring intense sedation or general anesthesia).

    In case of failure, the participant will be immediately discontinued from the study and the surgery will normally proceed with anesthetic procedure at the discretion of the Investigator. Anesthesia failure should be reported as an adverse event.


  10. Comparison between arms from the occurrence of adverse events [ Time Frame: 7 days ]
    Adverse event information will be collected from all participants on all visits


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883763


Contacts
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Contact: João B Garcia, MD/PhD +559888020622 jbgarcia@uol.com.br
Contact: Juliana S Mussalem, PhD +551137236483 juliana.mussalem@cristalia.com.br

Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
Investigators
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Principal Investigator: João B Garcia, MD/PhD HUUFMA - Hospital Universitário da Universidade Federal do Maranhão
More Information
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Responsible Party: Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier: NCT03883763    
Other Study ID Numbers: CRT090
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents