NCT03883763

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
3 years until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

February 8, 2023

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

March 11, 2019

Last Update Submit

February 7, 2023

Conditions

Spinal AnesthesiaVascular Surgery

Outcome Measures

Primary Outcomes (2)

  • Comparison between arms from latency to T10 dermatome sensitive block

    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

    20 minutes

  • Comparison between arms from the duration of the sensory block

    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

    24 hours

Secondary Outcomes (10)

  • Comparison between arms from the degree of motor blockage when blocking T10 sensitive

    20 minutes

  • Comparison between arms from the duration of the motor block

    24 hours

  • Comparison between arms from the highest level of sensory block

    3 hours

  • Comparison between arms from the time to reach the highest level of sensory block

    1 hour

  • Comparison between arms from the time for the 4-segment regression of the sensory block

    3 hours

  • +5 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL
Drug: bupivacaine S75:R25 plus 8% glucose

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

ACTIVE COMPARATOR
Drug: bupivacaine S50:R50 plus 8% glucose

Interventions

bupivacaine S75:R25 plus 8% glucoseDRUG

Spinal anesthesia, 20 mg

Hyperbaric Novabupi® 0.5% (bupivacaine S75:R25 + 8% glucose)
bupivacaine S50:R50 plus 8% glucoseDRUG

Spinal anesthesia, 20 mg

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEPEC

São Luís, Maranhão, 65020-600, Brazil

RECRUITING

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • João B Garcia, MD/PhD

    HUUFMA - Hospital Universitário da Universidade Federal do Maranhão

    PRINCIPAL INVESTIGATOR

Central Study Contacts

João B Garcia, MD/PhD

CONTACT

+559888020622jbgarcia@uol.com.br

Juliana S Mussalem, PhD

CONTACT

+551137236483juliana.mussalem@cristalia.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 21, 2019

Study Start

April 1, 2022

Primary Completion

April 30, 2023

Study Completion

November 30, 2023

Last Updated

February 8, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)