Clinical trial NCT01308047: Comparing Heavy Levobupivacaine With Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine.
Official title: Comparative Study of Non-inferiority Between Heavy Levobupivacaine With Enantiomeric Excess of 50% (Bupivacaine S75: R25) and Heavy Racemic Bupivacaine (Bupivacaine S50: R50) in Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Fracture of Lower Limb
Lead sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
Sponsor class: INDUSTRY
Collaborators: name: Irmandade da Santa Casa de Misericordia de Sao Paulo
name: Serviço Social da Indústria do Papel, Papelão e Cortiça do Estado de São Paulo
First posted: 2011-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time of latency for sensory block at T10 dermatome.
timeFrame: +/- 40 min after injection
Secondary outcomes:
measure: Sensory block duration
timeFrame: +/- 3 hours
measure: Motor Block Evaluation
timeFrame: +/- 30 min
measure: Maximum cranial dispersion verifying the largest metamer achieved.
timeFrame: +/- 45 min
measure: Evaluation of the cardiocirculatory and respiratory parameters
timeFrame: +/- 8 hours
measure: Time of regression of motor block by Bromage Scale
timeFrame: +/- 9 - 10 hours
measure: The residual analgesic effect
timeFrame: +/- 9-10 hours
measure: Anesthetic failure
timeFrame: +/- 45 min
measure: Adverse Events
timeFrame: +/- 8 - 12 hours
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Sepaco
city: São Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de São Paulo
Study officials:
affiliation: Irmandade da Santa Casa de Misericórdia de São Paulo
name: Ligia Mathias, PhD
role: PRINCIPAL_INVESTIGATOR
References: