Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00210132
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 26, 2015
Sponsor:
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 ClinicalTrials.gov identifier (NCT number): NCT00210132


Locations
Layout table for location information
France
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
Investigators
Layout table for investigator information
Principal Investigator: Jean-Pierre GEKIERE, MD Institut Bergonié
Layout table for additonal information
Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT00210132    
Other Study ID Numbers: IB2003-23
ROPAL 1
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
ropivacaine
inter pleural analgesia
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents