Assessment of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion (LEVOROPI)

January 19, 2012 updated by: Massimo Allegri, IRCCS Policlinico S. Matteo

Prospective Randomized Double-blinded Study of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Monza, Italy, 20052
        • Unità operativa di Anestesia e Rianimazione - Azienda Ospedaliera San Gerardo
    • Lombardia
      • Pavia, Lombardia, Italy, 27100
        • IRCCS Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: levobupivacaine
Drug: 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
Other Names:
  • Naropina
  • Chriocaina
Other: ropivacaine
Drug: 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
Other Names:
  • Naropina
  • Chriocaina

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma concentration of the local anesthetics in study
Time Frame: during 60h after surgery
Assessment of the equivalence of the systemic exposition of levobupivacaine and ropivacaine during 48h continuous epidural infusion with in a range of 15%.Blood samples (8) will be taken for farmacological assessment of local anesthetic plasma concentrations at time (hours) 0,+3h,+6h,+12h,+24h,+48h,+54h,+60h
during 60h after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the pharmacological profile of the local anesthetics in study
Time Frame: during 60h after surgery
Assessment of the therapeutic index (plasma concentration of the local anesthetics in study compared to those described in literature to be related to toxic effects).
during 60h after surgery
Difference between the to groups (at least 25%) in terms of pain control (1 episode of VAS>4)
Time Frame: Pain control (VAS, VASm, rescue dose) during the 72 h postsurgery
Pain control (VAS, VASm, rescue dose) during the 72 h postsurgery
Difference at least 20% in presentation of collateral effects between the two groups
Time Frame: Continuous assessment during the 72 h post-surgery
Continuous assessment during the 72 h post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Matteo

Investigators

  • Principal Investigator: Massimo Allegri, MD, IRCCS Policlinico San Matteo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

October 26, 2010

First Posted (Estimate)

October 27, 2010

Study Record Updates

Last Update Posted (Estimate)

January 20, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-019393-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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