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

Phase 4

Completed

• Conditions: Anesthesia; Surgery
• Interventions: Drug: local anesthetic

• Registration Number: NCT01229241
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

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

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 Timeline

• Study Start: 2005-07
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-19
• Last Update Posted: 2012-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levobupivacaine	local anesthetic	-
ropivacaine	local anesthetic	-

Primary Outcome Measures

Name	Time	Method
Plasma concentration of the local anesthetics in study	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 Outcome Measures

Name	Time	Method
Assessment of the pharmacological profile of the local anesthetics in study	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).
Difference between the to groups (at least 25%) in terms of pain control (1 episode of VAS>4)	Pain control (VAS, VASm, rescue dose) during the 72 h postsurgery
Difference at least 20% in presentation of collateral effects between the two groups	Continuous assessment during the 72 h post-surgery

Trial Locations

Locations (2)

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Lombardia, Italy

Unità Operativa di Anestesia e Rianimazione - Azienda Ospedaliera San Gerardo; 🇮🇹 Monza, Italy