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

Fracture of Lower Limb Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01308047
• Other study ID #: CRIST016
• Status: Withdrawn
• Phase: Phase 3
• First received: February 23, 2011
• Last updated: March 25, 2014

Study information

• Verified date: March 2014
• Source: Cristália Produtos Químicos Farmacêuticos Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fracture of Lower Limb

Intervention

Drug:
• Bupivacaine
single dose of 15mg by a slow injection rate of 1 ml/s

Locations

Country	Name	City	State
Brazil	Hospital Sepaco	São Paulo
Brazil	Irmandade da Santa Casa de Misericórdia de São Paulo	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Cristália Produtos Químicos Farmacêuticos Ltda.	Irmandade da Santa Casa de Misericordia de Sao Paulo, Serviço Social da Indústria do Papel, Papelão e Cortiça do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Motor Block Evaluation	Motor block evaluation by Bromage Scale every five minutes after puncture till 20 minutes.	+/- 30 min	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Anesthetic failure	Evaluation of the anesthetic failure (if occur)	+/- 45 min	No
Secondary	Adverse Events	During the study will be evaluate the presence of adverse event due to the anesthetic.	+/- 8 - 12 hours	No