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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210132
First received: September 12, 2005
Last updated: December 29, 2011
Last verified: October 2003
History of Changes
  Purpose

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 Intervention Phase
Postoperative Pain
Cancer
 Drug: Ropivacaine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Institut Bergonié:

Primary Outcome Measures:
  • 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:
  • To compare the morphine consumption during 48 hours
  • To determine ropivacaine plasmatic concentration by inter pleural road during first 48 hours

Enrollment: 90
Study Start Date: October 2003
Study Completion Date: February 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ropivacaine Drug: Ropivacaine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210132

Locations
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
Principal Investigator: Jean-Pierre GEKIERE, MD Institut Bergonié
  More Information

No publications provided

Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT00210132     History of Changes
Other Study ID Numbers: IB2003-23, ROPAL 1
Study First Received: September 12, 2005
Last Updated: December 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Thoracic surgery
postoperative pain
ropivacaine
inter pleural analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
Ropivacaine
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on June 18, 2013