---
title: Assessment of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion
nct_id: NCT01229241
overall_status: COMPLETED
phase: PHASE4
sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
study_type: INTERVENTIONAL
primary_condition: Anesthesia
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01229241.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01229241"
ct_last_update_post_date: 2012-01-20
last_seen_at: "2026-05-12T06:20:38.414Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Assessment of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion

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

**NCT ID:** [NCT01229241](https://clinicaltrials.gov/study/NCT01229241)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 181
- **Lead Sponsor:** Fondazione IRCCS Policlinico San Matteo di Pavia
- **Conditions:** Anesthesia, Surgery
- **Start Date:** 2005-07
- **Completion Date:** 2011-07
- **CT.gov Last Update:** 2012-01-20

## 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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 90 Years
- **Sex:** ALL
- **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
```

## Arms

- **levobupivacaine** (OTHER)
- **ropivacaine** (OTHER)

## 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

## Primary Outcomes

- **Plasma concentration of the local anesthetics in study** _(time frame: 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 Outcomes

- **Assessment of the pharmacological profile of the local anesthetics in study** _(time frame: during 60h after surgery)_
- **Difference between the to groups (at least 25%) in terms of pain control (1 episode of VAS>4)** _(time frame: Pain control (VAS, VASm, rescue dose) during the 72 h postsurgery)_
- **Difference at least 20% in presentation of collateral effects between the two groups** _(time frame: Continuous assessment during the 72 h post-surgery)_

## Locations (2)

- IRCCS Policlinico San Matteo, Pavia, Lombardy, Italy
- Unità Operativa di Anestesia e Rianimazione - Azienda Ospedaliera San Gerardo, Monza, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.irccs policlinico san matteo|pavia|lombardy|italy` — added _(2026-05-12)_
- `locations.unità operativa di anestesia e rianimazione - azienda ospedaliera san gerardo|monza||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01229241.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01229241*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*