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

August 27, 2007 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Frédéric Plantevin, MD
  • Phone Number: 33 1 42 11 44 37
  • Email: plantevin@igr.fr

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assess the influence of locoregional anesthesia on postoperative morphine consumption

Secondary Outcome Measures

Outcome Measure
Visual analog pain scale on the free flap donor site

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Principal Investigator: Frédéric Plantevin, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

August 28, 2007

Last Update Submitted That Met QC Criteria

August 27, 2007

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERONE
  • CSET 2003/1042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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