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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Fracture of Lower Limb
• Intervention / Treatment: Drug: Bupivacaine

Detailed 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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Irmandade Da Santa Casa de Misericordia de Sao Paulo
  • São Paulo, Brazil
    • Hospital SEPACO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
• Collaborators: Irmandade da Santa Casa de Misericordia de Sao Paulo; Serviço Social da Indústria do Papel, Papelão e Cortiça do Estado de São Paulo
• Investigators: Principal Investigator: Ligia Mathias, PhD, Irmandade Da Santa Casa de Misericordia de Sao Paulo

Study record dates

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: March 2, 2011
• First Posted (Estimate): March 3, 2011

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 25, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: CRIST016