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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Massimo Allegri, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT01229241
First received: August 16, 2010
Last updated: January 19, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Anesthesia
Surgery
 Drug: local anesthetic
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Double-blinded Study of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IRCCS Policlinico S. Matteo:

Primary Outcome Measures:
  • Plasma concentration of the local anesthetics in study [ Time Frame: during 60h after surgery ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Assessment of the pharmacological profile of the local anesthetics in study [ Time Frame: during 60h after surgery ] [ Designated as safety issue: Yes ]
    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).

  • 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 ] [ Designated as safety issue: No ]
  • Difference at least 20% in presentation of collateral effects between the two groups [ Time Frame: Continuous assessment during the 72 h post-surgery ] [ Designated as safety issue: No ]

Enrollment: 181
Study Start Date: July 2005
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Chriocaina
  • Naropina
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:
  • Chriocaina
  • Naropina

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229241

Locations
Italy
IRCCS Policlinico San Matteo
Pavia, Lombardia, Italy, 27100
Unità Operativa di Anestesia e Rianimazione - Azienda Ospedaliera San Gerardo
Monza, Italy, 20052
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Investigators
Principal Investigator: Massimo Allegri, MD IRCCS Policlinico San Matteo
  More Information

No publications provided

Responsible Party: Massimo Allegri, MD, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT01229241     History of Changes
Other Study ID Numbers: 2010-019393-32
Study First Received: August 16, 2010
Last Updated: January 19, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS Policlinico S. Matteo:
local anesthetic
epidural
pharmacokinetics
plasmatic concentration
epidural continuous infusion

Additional relevant MeSH terms:
Anesthetics, Local
Ropivacaine
Levobupivacaine
Bupivacaine
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013