Analgesia of Fibula Free Flap Donor Site by Peri-Neuronal... | NCT00181038

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

NCT00181038

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Unknown status

Last Update Posted

Aug 28, 2007Estimated

Enrollment

40Estimated

Phase

Phase 3

Conditions

Oropharyngeal Neoplasms

Interventions

Peri-Neuronal Catheter

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CSET 2003/1042

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2007

Last Update Posted Date

Aug 28, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
Peri-Neuronal Catheter	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the influence of locoregional anesthesia on postoperative morphine consumption

Secondary Outcomes

Measure	Description	Time Frame
Visual analog pain scale on the free flap donor site

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Frédéric Plantevin, MD	Contact	33 1 42 11 44 37		plantevin@igr.fr

Overall Officials

Name	Affiliation	Role
Frédéric Plantevin, MD	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave Roussy	Recruiting	Villejuif		94800	France

Condition Browse Module

MeSH Terms

ID	Term
D009959	Oropharyngeal Neoplasms

Ancestor Terms

ID	Term
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided