Clinical trial NCT01229241: Assessment of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion
Official title: Prospective Randomized Double-blinded Study of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Surgery
Keywords: local anesthetic
epidural
pharmacokinetics
plasmatic concentration
epidural continuous infusion
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Plasma concentration of the local anesthetics in study
timeFrame: during 60h after surgery
Secondary outcomes:
measure: Assessment of the pharmacological profile of the local anesthetics in study
timeFrame: during 60h after surgery
measure: Difference between the to groups (at least 25%) in terms of pain control (1 episode of VAS>4)
timeFrame: Pain control (VAS, VASm, rescue dose) during the 72 h postsurgery
measure: Difference at least 20% in presentation of collateral effects between the two groups
timeFrame: Continuous assessment during the 72 h post-surgery
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
state: Lombardia
city: Monza
country: Italy
facility: Unità Operativa di Anestesia e Rianimazione - Azienda Ospedaliera San Gerardo
Study officials:
affiliation: IRCCS Policlinico San Matteo
name: Massimo Allegri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perotti L, Cusato M, Ingelmo P, Niebel TL, Somaini M, Riva F, Tinelli C, De Andres J, Fanelli G, Braschi A, Regazzi M, Allegri M. A Comparison of Differences Between the Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion: A Prospective, Randomized, Multicenter, Double-Blind Controlled Trial. Anesth Analg. 2015 Aug;121(2):348-56. doi: 10.1213/ANE.0000000000000775.