Comparing Heavy Levobupivacaine With Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine.

Cristália Produtos Químicos Farmacêuticos Ltda.

Overview

The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.

The Heavy Levobupivacaine with Enantiomeric Excess of 50% was developed to be a safe local anesthetic replacing the Heavy Racemic Bupivacaine. This study will evaluate the non-inferiority regarding efficacy and safety of spinal anesthesia in orthopedic procedures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Conditions

Fracture of Lower Limb

Interventions

BupivacaineDRUG

single dose of 15mg by a slow injection rate of 1 ml/s

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * ASA (American Society of Anesthesiologists) I or ASA II * Spinal Anaesthesia for lower limb surgery * Patient Consent Exclusion Criteria: * relative or absolute contraindications for spinal anesthesia * history of hypersensitivity to the local anesthetics or components * opioids for anesthetic adjuvant * spinal lesions, peripheral neuropathies or any other neurologic disorders that leads to changes of sensitivity * Body mass index = or \> 35 * lumbar puncture difficulty * ventricular extrasystoles * dementia, others loss of cognitive ability * difficulty in the spine * spinal cord surgery * anaphylactic reactions or Stevens-johnson Syndrome * polytraumatism * alcoholism abuse and use of illicit substance * Changes in the blood test * Others conditions judged by investigator's opinion

Locations (2)

Hospital Sepaco

São Paulo, São Paulo, Brazil

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Time of latency for sensory block at T10 dermatome.

Evaluate the sensory block at T10 after the anesthetic injection through sensory stimulation by needle.

Time frame: +/- 40 min after injection

Secondary Outcomes

Sensory block duration

Verifying the duration of anesthesia from after puncture till the presence of positive sensitivity by needle stimulation region of the foot.

Time frame: +/- 3 hours

Motor Block Evaluation

Motor block evaluation by Bromage Scale every five minutes after puncture till 20 minutes.

Time frame: +/- 30 min

Maximum cranial dispersion verifying the largest metamer achieved.

Evaluated by needle stimulation every 2 minutes from the removal of post-puncture needle until the maximum extension time.

Time frame: +/- 45 min

Evaluation of the cardiocirculatory and respiratory parameters

Systolic and diastolic blood pressure (SBP and DBP), heart rate (HR), and oxygen saturation (SpO2) are evaluate during the study to measure the safety of cardiocirculatory and respiratory parameters

Time frame: +/- 8 hours

Time of regression of motor block by Bromage Scale

Will be measure the time of recovery of the motor block, the patient have to score note 4 of the Bromage Scale

Time frame: +/- 9 - 10 hours

The residual analgesic effect

Will be evaluated the end of the analgesic effect of the anesthetic solution when the patient asks for pain medication.

Data from ClinicalTrials.gov

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