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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
181
postoperative 48h epidural continuous infusion, 1. ropivacaine 0,2% (250ml)+ sufentanil 0,75mcg/ml 2. levobupivacaine 0,125% (250ml)+ sufentanil 0,75mcg/ml
IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
Unità Operativa di Anestesia e Rianimazione - Azienda Ospedaliera San Gerardo
Monza, Italy
Plasma concentration of the local anesthetics in study
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
Time frame: during 60h after surgery
Assessment of the pharmacological profile of the local anesthetics in study
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).
Time frame: 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
Difference at least 20% in presentation of collateral effects between the two groups
Time frame: Continuous assessment during the 72 h post-surgery
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