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

Phase 3

Withdrawn

• Conditions: Fracture of Lower Limb
• Interventions: Drug: Bupivacaine

• Registration Number: NCT01308047
• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.

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.

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 Timeline

• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-03
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-25
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine S75:R25	Bupivacaine	3 ml for subarachnoid block
bupivacaine (S50:R50)	Bupivacaine	3 ml subarachnoid block

Primary Outcome Measures

Name	Time	Method
Time of latency for sensory block at T10 dermatome.	+/- 40 min after injection	Evaluate the sensory block at T10 after the anesthetic injection through sensory stimulation by needle.

Secondary Outcome Measures

Name	Time	Method
Sensory block duration	+/- 3 hours	Verifying the duration of anesthesia from after puncture till the presence of positive sensitivity by needle stimulation region of the foot.
Motor Block Evaluation	+/- 30 min	Motor block evaluation by Bromage Scale every five minutes after puncture till 20 minutes.
Maximum cranial dispersion verifying the largest metamer achieved.	+/- 45 min	Evaluated by needle stimulation every 2 minutes from the removal of post-puncture needle until the maximum extension time.
Evaluation of the cardiocirculatory and respiratory parameters	+/- 8 hours	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
Time of regression of motor block by Bromage Scale	+/- 9 - 10 hours	Will be measure the time of recovery of the motor block, the patient have to score note 4 of the Bromage Scale
The residual analgesic effect	+/- 9-10 hours	Will be evaluated the end of the analgesic effect of the anesthetic solution when the patient asks for pain medication.
Anesthetic failure	+/- 45 min	Evaluation of the anesthetic failure (if occur)
Adverse Events	+/- 8 - 12 hours	During the study will be evaluate the presence of adverse event due to the anesthetic.

Trial Locations

Locations (2)

Irmandade da Santa Casa de Misericórdia de São Paulo; 🇧🇷 São Paulo, Brazil

Hospital Sepaco; 🇧🇷 São Paulo, Brazil