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NCT00210132 Clinical Trial

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

Cancer Clinical Trial

— ROPAL 1  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00210132
Other study ID # IB2003-23
Secondary ID ROPAL 1
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated November 25, 2015
Start date October 2003
Est. completion date February 2008

Study information
Verified date November 2015
Source Institut Bergonié
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date February 2008
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ropivacaine

Locations
Country Name City State
France Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest Bordeaux

Sponsors (1)
Lead Sponsor Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To compare the morphine consumption during 48 hours
Secondary To determine ropivacaine plasmatic concentration by inter pleural road during first 48 hours
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