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OpenTrials
Completed

NCT Number: NCT00210132

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Bordeaux, 33076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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

  1. Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study title

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

Acronym: ROPAL-1

Important dates

Study start
2003
Primary completion
2006
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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