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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Spinal anesthesia, 20 mg
Spinal anesthesia, 20 mg
CEPEC
São Luís, Maranhão, Brazil
RECRUITINGComparison 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
Time frame: 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
Time frame: 24 hours
Comparison between arms from the degree of motor blockage when blocking T10 sensitive
The motor block will be evaluated by the modified Bromage scale. The degree of motor block will be assessed when the sensory block reaches T10. The motor block will be evaluated every 5 minutes from the end of the anesthetic injection (time 0) through the modified Bromage scale: * 0 = without motor block, * 1 = blocked hip, * 2 = blocked hip and knee, * 3 = blocked hip, knee and ankle. Will be recorded: * the degree of motor blockage when the sensory block reaches T10, * the time to reach the maximum block, * time for full recovery (Bromage score 0).
Time frame: 20 minutes
Comparison between arms from the duration of the motor block
Duration of motor block will be considered as the time interval between needle withdrawal after puncture and return to score 0 on the modified Bromage scale. Time will be recorded to reach grade 3 motor block and at the end of surgery. During anesthesia recovery, evaluations will be performed every 15 minutes
Time frame: 24 hours
Comparison between arms from the highest level of sensory block
Time frame: 3 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Comparison between arms from the time to reach the highest level of sensory block
Time frame: 1 hour
Comparison between arms from the time for the 4-segment regression of the sensory block
The height of the sensitive block will be evaluated every 5 minutes until the maximum level is reached. From this point, the height of the block will be evaluated every 10 minutes until the regression of 4 levels
Time frame: 3 hours
Comparison between arms of respiratory and cardiovascular safety
Evidenced by the incidence, severity and causality of clinically significant SpO2 changes. Every 5 minutes SpO2 will be recorded until completing 60 minutes, every 10 minutes until completing 120 minutes, every 20 minutes until 12 hours.
Time frame: 12 hours
Comparison between arms of cardiovascular safety
Evidenced by the incidence, severity and causality of clinically significant changes in blood pressure measured automatically by cardiac monitoring. Every 5 minutes blood pressure will be recorded until completing 60 minutes, every 10 minutes until completing 120 minutes, every 20 minutes until completing 180 minutes and every 30 minutes until complete recovery of the motor function.
Time frame: 24 hours
Comparison between arms of cardiovascular safety
Evidenced by the incidence, severity and causality of clinically significant changes in heart rate measured automatically by cardiac monitoring. Every 5 minutes heart rate will be recorded until completing 60 minutes, every 10 minutes until completing 120 minutes, every 20 minutes until completing 180 minutes and every 30 minutes until complete recovery of the motor function
Time frame: 12 hours
Comparison between arms from the percentage of motor and sensory block failure
After the needle has been withdrawn, the anesthetic should be installed for up to 20 minutes. If no sensory and / or motor blockage is observed after this period, the Investigator will indicate that there was an anesthetic failure that should be classified as: A. total block failure (absence of anesthesia in sensory and motor aspects with preserved sensitivity of the perineal region) B. partial failure (when any area below the T10 dermatome shows signs of analgesia or motor block, but surgery can not be performed, requiring intense sedation or general anesthesia). In case of failure, the participant will be immediately discontinued from the study and the surgery will normally proceed with anesthetic procedure at the discretion of the Investigator. Anesthesia failure should be reported as an adverse event.
Time frame: 20 minutes
Comparison between arms from the occurrence of adverse events
Adverse event information will be collected from all participants on all visits
Time frame: 7 days