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

NCT00210132 | Completed Phase 2 Results

• 1 other identifier: IB2003-23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain; Cancer

Keywords

Thoracic surgery; postoperative pain; ropivacaine; inter pleural analgesia

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy

  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.

  Between surgery and up to 48 hours

Secondary Outcomes (1)

• Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy

  between surgery and 48 hours

Study Arms (2)

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.

Drug: Ropivacaine

Reference Arm

SHAM COMPARATOR

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

Drug: Reference

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.

Ropivacaine Arm

Reference DRUG

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

Reference Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Ropivacaine hypersensibility
• Psychiatric disorders
• Incapacity of using visual analog scale

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

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

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Pain, Postoperative; Neoplasms

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Simone Mathoulin-Pélissier, Director of Clinical Trials Unit
• Organization: Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

s.mathoulin@bordeaux.unicancer.fr

+33 5 56 33 33 33

Study Officials

• Jean-Pierre GEKIERE, MD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Individual series of products were prepared by the Pharmacy according to a list (randomization list pre-established by the biostatistics department), which was not accessible to anyone until the results were analyzed. The treatments were sent by the pharmacy to the operating room in the form of pre-filled syringes with no distinguishing marks indicating the treatment group. Blindness was maintained during the evaluation period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2003
• Primary Completion: June 30, 2006
• Study Completion: February 28, 2008
• Last Updated: September 8, 2025
• Results First Posted: September 8, 2025

Record last verified: 2025-08

Locations

FR (1)