NCT01229241

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

Prospective Randomized Double-blinded Study of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Anesthesia
• Surgery

Interventions

Type	Name	Description
DRUG	local anesthetic	postoperative 48h epidural continuous infusion, 1. ropivacaine 0,2% (250ml)+ sufentanil 0,75mcg/ml 2. levobupivacaine 0,125% (250ml)+ sufentanil 0,75mcg/ml

Timeline

• Start date: 2005-07-01
• Primary completion: 2011-06-01
• Completion: 2011-07-01
• First posted: 2010-10-27
• Last updated: 2012-01-20

Locations

2 sites across 1 country: Italy