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Completed

NCT Number: NCT01229241

Assessment 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.

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Key information

Conditions

Anesthesia Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IRCCS Policlinico San Matteo, Pavia, Lombardy, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local anesthetic

Drug

postoperative 48h epidural continuous infusion,

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

Other names: Chriocaina, Naropina

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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

  3. Difference at least 20% in presentation of collateral effects between the two groups

    Time frame: Continuous assessment during the 72 h post-surgery

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Acronym: LEVOROPI

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Oct 27, 2010
Registry last updated
Jan 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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