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Analgesia of Fibula Free Flap Donor Site by Peri-Neuronal Catheter in Oro-Pharyngeal Carcinoma Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: September 13, 2005
Last updated: August 27, 2007
Last verified: September 2006
This trial examines the analgesia of the fibula free flap donor site by peri-neuronal catheter in oro-pharyngeal carcinoma surgery by comparing continuous infusion of a local anesthetic with systemic multimodal analgesia.

Condition Intervention Phase
Oropharyngeal Neoplasms
Device: Peri-Neuronal Catheter
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Analgesia of Fibula Free Flap Donor Site by Peri-Neuronal Catheter in Oro-Pharyngeal Carcinoma Surgery: Comparing Continuous Infusion of Local Anesthetic With Systemic Multimodal Analgesia

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Assess the influence of locoregional anesthesia on postoperative morphine consumption

Secondary Outcome Measures:
  • Visual analog pain scale on the free flap donor site

Estimated Enrollment: 40
Study Start Date: June 2004

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients scheduled for oro-pharyngeal carcinoma surgery with reconstruction by fibula free flap

Exclusion Criteria:

  • Allergy to propofol or local anesthetic (ropivacaine)
  • Severe renal or cardiac failure
  Contacts and Locations
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Please refer to this study by its identifier: NCT00181038

Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Frédéric Plantevin, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information Identifier: NCT00181038     History of Changes
Other Study ID Numbers: PERONE  CSET 2003/1042 
Study First Received: September 13, 2005
Last Updated: August 27, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Oro-Pharyngeal Carcinoma Surgery

Additional relevant MeSH terms:
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases processed this record on December 07, 2016