Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery

Phase 2

Completed

• Conditions: Postoperative Pain; Cancer
• Interventions: Drug: Ropivacaine; Drug: Reference

• Registration Number: NCT00210132
• Lead Sponsor: Institut Bergonié

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2006-06-30
• Study Completion: 2008-02-28
• Status Verified: 2025-08
• Results First Submitted: 2025-08-20
• Results First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Results First Posted: 2025-09-08
• Last Update Posted: 2025-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine Arm	Ropivacaine	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	Reference	8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy	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 Outcome Measures

Name	Time	Method
Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy	between surgery and 48 hours	Morphine consumption during the 48 hours following surgery. Morphine consumption is defined as the number of morphine boluses (1 bolus = 1mg).

Trial Locations

Locations (1)

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