Study Stopped
The Sponsor has no interest in continuing the study.
Comparing Heavy Levobupivacaine With Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine.
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.
1 other identifier
interventional
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2011
CompletedFirst Posted
Study publicly available on registry
March 3, 2011
CompletedMarch 26, 2014
March 1, 2014
February 23, 2011
March 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Sensory block duration
+/- 3 hours
Motor Block Evaluation
+/- 30 min
Maximum cranial dispersion verifying the largest metamer achieved.
+/- 45 min
Evaluation of the cardiocirculatory and respiratory parameters
+/- 8 hours
Time of regression of motor block by Bromage Scale
+/- 9 - 10 hours
- +3 more secondary outcomes
Study Arms (2)
bupivacaine S75:R25
EXPERIMENTAL3 ml for subarachnoid block
bupivacaine (S50:R50)
ACTIVE COMPARATOR3 ml subarachnoid block
Interventions
single dose of 15mg by a slow injection rate of 1 ml/s
Eligibility Criteria
You may qualify if:
- ASA (American Society of Anesthesiologists) I or ASA II
- Spinal Anaesthesia for lower limb surgery
- Patient Consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Sepaco
São Paulo, São Paulo, Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ligia Mathias, PhD
Irmandade da Santa Casa de Misericórdia de São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2011
First Posted
March 3, 2011
Last Updated
March 26, 2014
Record last verified: 2014-03