Assessment of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2011-07-31

Brief Summary

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The aim of the study is the assessment of the systemic absorption of local anesthetics during continuous epidural infusion for postoperative pain control.

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Detailed Description

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In literature the systemic toxicity of bupivacaine is widely demonstrated, like the minor toxicity of levobupivacaine and ropivacaine at the same anesthetic potency. The are actually no studies in humans confronting levobupivacaine and ropivacaine under the aspect of efficacy and toxicity.The aim of the study is the assessment of the systemic absorption of local anesthetics during continuous epidural infusion for postoperative pain control.

Primary outcome:

Assessment of the plasmatic equimolar concentrations of levobupivacaine and ropivacaine during continuous epidural infusion

Secondary outcome:

Assessment of the safety level of the local anesthetic (major difference between haematic concentration of the local anesthetic and neuro-cardiotoxic dose).

Difference of the analgesic efficacy between levobupivacaine and ropivacaine. Differences in collateral effects due to the local anesthetic: hypotension and sensitive block.

Prospective randomized double-blinded clinical trial

Conditions

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Anesthesia Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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levobupivacaine

Group Type OTHER

local anesthetic

Intervention Type DRUG

postoperative 48h epidural continuous infusion,

1. ropivacaine 0,2% (250ml)+ sufentanil 0,75mcg/ml
2. levobupivacaine 0,125% (250ml)+ sufentanil 0,75mcg/ml

ropivacaine

Group Type OTHER

local anesthetic

Intervention Type DRUG

postoperative 48h epidural continuous infusion,

1. ropivacaine 0,2% (250ml)+ sufentanil 0,75mcg/ml
2. levobupivacaine 0,125% (250ml)+ sufentanil 0,75mcg/ml

Interventions

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local anesthetic

postoperative 48h epidural continuous infusion,

1. ropivacaine 0,2% (250ml)+ sufentanil 0,75mcg/ml
2. levobupivacaine 0,125% (250ml)+ sufentanil 0,75mcg/ml

Intervention Type DRUG

Other Intervention Names

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Chriocaina Naropina

Eligibility Criteria

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Inclusion Criteria

* ASA I or ASA II
* Scheduled for major surgery
* written informed consent

Exclusion Criteria

* ASA III, IV
* Emergency surgery
* Recovery in intensive care unit after surgery
* habitual opioid consumption
* cognitive or mental alterations
* coagulopathy
* piastrinemia \< 100.000/mm3

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No