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

Primary Purpose

Postoperative Pain, Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Thoracic surgery, postoperative pain, ropivacaine, inter pleural analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ropivacaine

Arm Description

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
November 25, 2015
Sponsor
Institut Bergonié
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1. Study Identification

Unique Protocol Identification Number
NCT00210132
Brief Title
Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery
Acronym
ROPAL 1
Official Title
Randomized Trial to Evaluate the Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié

4. Oversight

5. Study Description

Brief Summary
The purposes of this study are: To determine the efficacy of inter pleural analgesia To determine the plasmatic concentration of ropivacaine by inter pleural road

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Cancer
Keywords
Thoracic surgery, postoperative pain, ropivacaine, inter pleural analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To compare the morphine consumption during 48 hours
Title
To determine ropivacaine plasmatic concentration by inter pleural road during first 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre GEKIERE, MD
Organizational Affiliation
Institut Bergonié
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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