---
title: Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery
nct_id: NCT00210132
overall_status: COMPLETED
phase: PHASE2
sponsor: Institut Bergonié
study_type: INTERVENTIONAL
primary_condition: Postoperative Pain
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00210132.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00210132"
ct_last_update_post_date: 2025-09-08
last_seen_at: "2026-05-12T07:24:52.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery

**Official Title:** Randomized Trial to Evaluate the Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery

**NCT ID:** [NCT00210132](https://clinicaltrials.gov/study/NCT00210132)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** Institut Bergonié
- **Conditions:** Postoperative Pain, Cancer
- **Start Date:** 2003-10-01
- **Completion Date:** 2008-02-28
- **CT.gov Last Update:** 2025-09-08

## Brief Summary

Thoracic surgery via posterolateral thoracotomy causes significant postoperative pain.

There are several methods of postoperative pain relief, including intravenous analgesics and local-regional analgesia techniques. Although thoracic epidural remains the gold standard, it is not without complications, which are rare but serious, and should be reserved for trained teams or patients with high morbidity.

Intrapleural analgesia is a simple method, performed by the surgeon intraoperatively.

Its effectiveness is controversial and the results remain inconsistent. Ropivacaine is a recently marketed local anesthetic with a modest vasoconstrictive effect. The variation in plasma levels of ropivacaine obtained by this technique has not yet been evaluated.

The purposes of this study are:

1. To determine the efficacy of inter pleural analgesia
2. To determine the plasmatic concentration of ropivacaine by inter pleural road

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Thoracotomy for oncology thoracic surgery
* Secondary or primary cancer
* American Society of Anesthesiology (ASA) class 1 or 2

Exclusion Criteria:

* Ropivacaine hypersensibility
* Psychiatric disorders
* Incapacity of using visual analog scale
```

## Arms

- **Ropivacaine Arm** (EXPERIMENTAL) — ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours.

Treatment administration = every 6 hours for 48 hours.
- **Reference Arm** (SHAM_COMPARATOR) — 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.

## Interventions

- **Ropivacaine** (DRUG) — ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours.

Treatment administration = every 6 hours for 48 hours.
- **Reference** (DRUG) — 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.

## Primary Outcomes

- **Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy** _(time frame: Between surgery and up to 48 hours)_ — Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever).

A participant is considered to have major pain if VAS score is \>= 70.

## Secondary Outcomes

- **Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy** _(time frame: between surgery and 48 hours)_

## Locations (1)

- Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest, Bordeaux, France

## 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.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.institut bergonié - centre régional de luttre contre le cancer de bordeaux et du sud ouest|bordeaux||france` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00210132*  
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