Fracture of Lower Limb
Conditions
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.
Interventions
DRUGBupivacaine
single dose of 15mg by a slow injection rate of 1 ml/s
Sponsors
Irmandade da Santa Casa de Misericordia de Sao Paulo
Serviço Social da Indústria do Papel, Papelão e Cortiça do Estado de São Paulo
Cristália Produtos Químicos Farmacêuticos Ltda.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of latency for sensory block at T10 dermatome. | +/- 40 min after injection | Evaluate the sensory block at T10 after the anesthetic injection through sensory stimulation by needle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor Block Evaluation | +/- 30 min | Motor block evaluation by Bromage Scale every five minutes after puncture till 20 minutes. |
| Maximum cranial dispersion verifying the largest metamer achieved. | +/- 45 min | Evaluated by needle stimulation every 2 minutes from the removal of post-puncture needle until the maximum extension time. |
| Evaluation of the cardiocirculatory and respiratory parameters | +/- 8 hours | 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 |
| Sensory block duration | +/- 3 hours | Verifying the duration of anesthesia from after puncture till the presence of positive sensitivity by needle stimulation region of the foot. |
| The residual analgesic effect | +/- 9-10 hours | Will be evaluated the end of the analgesic effect of the anesthetic solution when the patient asks for pain medication. |
| Anesthetic failure | +/- 45 min | Evaluation of the anesthetic failure (if occur) |
| Adverse Events | +/- 8 - 12 hours | During the study will be evaluate the presence of adverse event due to the anesthetic. |
| Time of regression of motor block by Bromage Scale | +/- 9 - 10 hours | Will be measure the time of recovery of the motor block, the patient have to score note 4 of the Bromage Scale |
Countries
Brazil
Outcome results
None listed