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
  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:


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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014