Anesthesia, Surgery
Conditions
Keywords
local anesthetic, epidural, pharmacokinetics, plasmatic concentration, epidural continuous infusion
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
Interventions
DRUGlocal anesthetic
postoperative 48h epidural continuous infusion, 1. ropivacaine 0,2% (250ml)+ sufentanil 0,75mcg/ml 2. levobupivacaine 0,125% (250ml)+ sufentanil 0,75mcg/ml
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed