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

Primary Purpose

Oropharyngeal Neoplasms

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Peri-Neuronal Catheter

About this trial

This is an interventional treatment trial for Oropharyngeal Neoplasms focused on measuring Oro-Pharyngeal Carcinoma Surgery

Eligibility Criteria

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

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

Sites / Locations

Institut Gustave RoussyRecruiting

Outcomes

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

Full Information

NCT ID

NCT00181038

First Posted

September 13, 2005

Last Updated

August 27, 2007

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

1. Study Identification

Unique Protocol Identification Number

NCT00181038

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Unknown status

Study Start Date

June 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oropharyngeal Neoplasms

Keywords

Oro-Pharyngeal Carcinoma Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Peri-Neuronal Catheter

Primary Outcome Measure Information:

Title

Assess the influence of locoregional anesthesia on postoperative morphine consumption

Secondary Outcome Measure Information:

Title

Visual analog pain scale on the free flap donor site

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Frédéric Plantevin, MD

Phone

33 1 42 11 44 37

plantevin@igr.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frédéric Plantevin, MD

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Gustave Roussy

City

Villejuif

ZIP/Postal Code

94800

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frédéric Plantevin, MD

Phone

33 1 42 11 44 37

plantevin@igr.fr

12. IPD Sharing Statement

Learn more about this trial

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

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