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

This study is currently recruiting participants.

Verified by Institut Gustave Roussy, September 2006

Sponsored by:	Institut Gustave Roussy
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00181038

Purpose

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 III

MedlinePlus related topics: Anesthesia Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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 Institut Gustave Roussy:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181038

Contacts

Contact: Frédéric Plantevin, MD

33 1 42 11 44 37

plantevin@igr.fr

Locations

France
Institut Gustave Roussy	Recruiting
Villejuif, France, 94800
Contact: Frédéric Plantevin, MD 33 1 42 11 44 37 plantevin@igr.fr

Sponsors and Collaborators

Institut Gustave Roussy

Investigators

Principal Investigator:

Frédéric Plantevin, MD

Institut Gustave Roussy

More Information

Study ID Numbers:	PERONE, CSET 2003/1042
Study First Received:	September 13, 2005
Last Updated:	August 27, 2007
ClinicalTrials.gov Identifier:	NCT00181038
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Gustave Roussy:

Oro-Pharyngeal Carcinoma Surgery

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Pharyngeal Neoplasms
Stomatognathic Diseases

Pharyngeal Diseases
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009