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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

August 16, 2010
January 19, 2012
July 2005
June 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01229241 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assessment of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion
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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Anesthesia
  • Surgery
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
  • levobupivacaine
    Intervention: Drug: local anesthetic
  • ropivacaine
    Intervention: Drug: local anesthetic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
July 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01229241
2010-019393-32
Yes
Massimo Allegri, IRCCS Policlinico S. Matteo
IRCCS Policlinico S. Matteo
Not Provided
Principal Investigator: Massimo Allegri, MD IRCCS Policlinico San Matteo
IRCCS Policlinico S. Matteo
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP