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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Fracture of Lower Limb

Intervention / Treatment
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* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bupivacaine S75:R25<br>3 ml for subarachnoid block | Drug: Bupivacaine<br>* single dose of 15mg by a slow injection rate of 1 ml/s<br>* Other names: marcaine;|
| Active Comparator: bupivacaine (S50:R50)<br>3 ml subarachnoid block | Drug: Bupivacaine<br>* single dose of 15mg by a slow injection rate of 1 ml/s<br>* Other names: marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of latency for sensory block at T10 dermatome. | Evaluate the sensory block at T10 after the anesthetic injection through sensory stimulation by needle. | +/- 40 min after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory block duration | Verifying the duration of anesthesia from after puncture till the presence of positive sensitivity by needle stimulation region of the foot. | +/- 3 hours | 
| Motor Block Evaluation | Motor block evaluation by Bromage Scale every five minutes after puncture till 20 minutes. | +/- 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. | +/- 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 | +/- 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 | +/- 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. | +/- 9-10 hours | 
| Anesthetic failure | Evaluation of the anesthetic failure (if occur) | +/- 45 min | 
| Adverse Events | During the study will be evaluate the presence of adverse event due to the anesthetic. | +/- 8 - 12 hours |