Orthopedic Disorder of Spine Clinical Trial
Official title:
Study Phase III to Evaluate the Noninferiority of Heavy Levobupivacaine 50% Enantiomeric Excess (Levobupivacaine S75:R25) Compared to Racemic Heavy Bupivacaine (Bupivacaine S50:R50) in Spinal Anesthesia for Lower Limb Orthopedic Procedures
Verified date | July 2017 |
Source | Cristália Produtos Químicos Farmacêuticos Ltda. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clinical trial phase III, noninferiority, controlled, double-blind, randomized. The purpose of this study is to evaluate the noninferiority between Levobupivacaine and Bupivacaine in spinal anesthesia.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients of both sexes; - Age between 18 and 80 years; - Risk anesthetic classified as ASA I or ASA II, according to the American Society of Anesthesiology; - What have indication for spinal orthopedic surgery in the lower limbs; - Have agreed to participate and signed the informed consent form. Exclusion Criteria: - Absolute or relative contraindications to spinal anesthesia; - Hypersensitivity or intolerance to local anesthetics or to components of the formula; - Spinal cord injuries, peripheral neuropathy or other neurological condition that lead to sensitivity and/ or motor function disorder; - Dementia, mental retardation and others important cognitive changes; - Obesity with a body mass index ( BMI ) = 35 or difficulty in executing the puncture; - Anatomical column difficulty in the opinion of the investigator; - Previous spine surgical intervention; - Polytrauma; - Tattoo at the puncture site; - Alcoholism; - Abuse of illicit substances; - Antecedents of severe anaphylactic reactions or Steven - Johnson disease; - Changes in security checks; - Participation in a clinical study in the 12 months preceding this inclusion; - Pregnancy and lactation; - Any other condition that in the opinion of the investigator, may lead to increased risk for the patient. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Ernesto Dornelles | Porto Alegre | RS |
Brazil | IMIP - Instituto de Medicina Integral Prof. Fernando Figueira | Recife | PE |
Brazil | Hospital de Base de São José do Rio Preto /SP | São José do Rio Preto | SP |
Brazil | CEMEC - Multidisciplinary Center of Clinical Studies | São Paulo | |
Brazil | Hospital das Clínicas da Faculdade de Medicina da USP / SP | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Cristália Produtos Químicos Farmacêuticos Ltda. | Newco Trials Pesquisa Científica Ltda |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time of latency to achieve sensitive block of T10. | The interval of time between the withdrawal of the needle at the end of local anesthetic injection and the absence of response to sensory stimulus in the region corresponding to the T10. | 01 day. | |
Primary | Duration time of the sensory block of T10. | Duration of anesthesia as for the sensory aspect through a needle stimulus in the anterior side of the foot. | 01 day. | |
Secondary | Sensory block intensity. | Ability of the patient to move their lower limbs, assessed by Bromage scale. | 02 days. | |
Secondary | Motor block duration. | Time interval between the end of anesthetic injection and the return to 0 score in modified Bromage scale. | 02 days. | |
Secondary | Cardiovascular safety. | Incidence and severity of hemodynamic (BP and HR) and respiratory (SpO2) alterations. | 02 days. | |
Secondary | Block failure. | To evaluate the absence of signs of analgesia or motor block for at least 20 minutes after anesthetic injection in the sensitive region studied. | 02 days. | |
Secondary | Adverse events. | To evaluate the occurrence of adverse events regarding the frequency, duration, severity and causal relationship with the study medication. | 02 days. |
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