Not provided
Not provided
Not provided
Not provided
Not provided
The Sponsor has no interest in continuing the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Irmandade da Santa Casa de Misericordia de Sao Paulo | OTHER |
| Serviço Social da Indústria do Papel, Papelão e Cortiça do Estado de São Paulo | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bupivacaine S75:R25 | Experimental | 3 ml for subarachnoid block |
|
| bupivacaine (S50:R50) | Active Comparator | 3 ml subarachnoid block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | single dose of 15mg by a slow injection rate of 1 ml/s |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ligia Mathias, PhD | Irmandade da Santa Casa de Misericórdia de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sepaco | São Paulo | São Paulo | Brazil | |||
| Irmandade da Santa Casa de Misericórdia de São Paulo |
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| São Paulo |
| São Paulo |
| Brazil |
| D000588 |
| Amines |