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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fracture of Lower Limb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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bupivacaine S75:R25

3 ml for subarachnoid block

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

single dose of 15mg by a slow injection rate of 1 ml/s

bupivacaine (S50:R50)

3 ml subarachnoid block

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

single dose of 15mg by a slow injection rate of 1 ml/s

Interventions

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Bupivacaine

single dose of 15mg by a slow injection rate of 1 ml/s

Intervention Type DRUG

Other Intervention Names

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marcaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes