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

NCT ID: NCT00210132

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-01
• Study Completion Date: 2008-02-28

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

Conditions

Postoperative Pain; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ropivacaine Arm

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.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: 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 Arm

8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.

Group Type: SHAM_COMPARATOR

Reference

Intervention Type: DRUG

8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.

Interventions

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.

Intervention Type: DRUG

Reference

8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pierre GEKIERE, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Bergonié

Locations

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

Bordeaux, , France

Countries

France

Other Identifiers

IB2003-23

Identifier Type: -

Identifier Source: org_study_id