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

Surgery Clinical Trial

— LEVOROPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229241
• Other study ID #: 2010-019393-32
• Status: Completed
• Phase: Phase 4
• First received: August 16, 2010
• Last updated: January 19, 2012
• Start date: July 2005
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of the study is the assessment of the systemic absorption of local anesthetics during continuous epidural infusion for postoperative pain control.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Surgery

Intervention

Drug:
• local anesthetic
postoperative 48h epidural continuous infusion, ropivacaine 0,2% (250ml)+ sufentanil 0,75mcg/ml levobupivacaine 0,125% (250ml)+ sufentanil 0,75mcg/ml

Locations

Country	Name	City	State
Italy	Unità Operativa di Anestesia e Rianimazione - Azienda Ospedaliera San Gerardo	Monza
Italy	IRCCS Policlinico San Matteo	Pavia	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	Difference at least 20% in presentation of collateral effects between the two groups		Continuous assessment during the 72 h post-surgery	No