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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levobupivacaine | Other |
| |
| ropivacaine | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local anesthetic | Drug | postoperative 48h epidural continuous infusion,
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | during 60h after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | during 60h after surgery |
| Difference between the to groups (at least 25%) in terms of pain control (1 episode of VAS>4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Allegri, MD | IRCCS Policlinico San Matteo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Matteo | Pavia | Lombardy | 27100 | Italy | ||
| Unità Operativa di Anestesia e Rianimazione - Azienda Ospedaliera San Gerardo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25977992 | Derived | 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. |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
| 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 |
| Monza |
| 20052 |
| Italy |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |