NCT00181038

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

August 28, 2007

Status Verified

September 1, 2006

First QC Date

September 13, 2005

Last Update Submit

August 27, 2007

Conditions

Oropharyngeal Neoplasms

Keywords

Oro-Pharyngeal Carcinoma Surgery

Outcome Measures

Primary Outcomes (1)

  • Assess the influence of locoregional anesthesia on postoperative morphine consumption

Secondary Outcomes (1)

  • Visual analog pain scale on the free flap donor site

Interventions

Peri-Neuronal CatheterDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Allergy to propofol or local anesthetic (ropivacaine)
  • Severe renal or cardiac failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Frédéric Plantevin, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Plantevin, MD

CONTACT

33 1 42 11 44 37plantevin@igr.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

June 1, 2004

Last Updated

August 28, 2007

Record last verified: 2006-09

Locations

FR(1)