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Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery (ROPAL 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210132
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 26, 2015
Information provided by (Responsible Party):
Institut Bergonié

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Cancer Drug: Ropivacaine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial to Evaluate the Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery
Study Start Date : October 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ropivacaine Drug: Ropivacaine

Primary Outcome Measures :
  1. To compare the incidence and the score of pain between the patients with ropivacaine and the patients without ropivacaine delivered by inter pleural road

Secondary Outcome Measures :
  1. To compare the morphine consumption during 48 hours
  2. To determine ropivacaine plasmatic concentration by inter pleural road during first 48 hours

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210132

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Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
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Principal Investigator: Jean-Pierre GEKIERE, MD Institut Bergonié
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Responsible Party: Institut Bergonié Identifier: NCT00210132    
Other Study ID Numbers: IB2003-23
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015
Keywords provided by Institut Bergonié:
Thoracic surgery
postoperative pain
inter pleural analgesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents