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

NCT01229241 | Completed Phase 4 DMC

• 1 other identifier: 2010-019393-32
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 2

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.

Conditions

Anesthesia; Surgery

Keywords

local anesthetic; epidural; pharmacokinetics; plasmatic concentration; epidural continuous infusion

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Assessment of the pharmacological profile of the local anesthetics in study

  during 60h after surgery

• 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

Study Arms (2)

levobupivacaine

OTHER

Drug: local anesthetic

ropivacaine

OTHER

Drug: local anesthetic

Interventions

local anesthetic DRUG

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

Also known as: Chriocaina, Naropina

levobupivacaine; ropivacaine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I or ASA II
• Scheduled for major surgery
• written informed consent

You may not qualify if:

• ASA III, IV
• Emergency surgery
• Recovery in intensive care unit after surgery
• habitual opioid consumption
• cognitive or mental alterations
• coagulopathy
• piastrinemia \< 100.000/mm3

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (2)

IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

Unità Operativa di Anestesia e Rianimazione - Azienda Ospedaliera San Gerardo

Monza, 20052, Italy

Location

Related Publications (1)

• 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.

  PMID: 25977992 DERIVED

MeSH Terms

Interventions

Anesthetics, Local

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Massimo Allegri, MD

  IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: October 27, 2010
• Study Start: July 1, 2005
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 20, 2012

Record last verified: 2012-01

Locations

IT (2)