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NCT00181038 Clinical Trial

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

Oropharyngeal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00181038
Other study ID # PERONE
Secondary ID CSET 2003/1042
Status Recruiting
Phase Phase 3
First received September 13, 2005
Last updated August 27, 2007
Start date June 2004

Study information
Verified date September 2006
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Frédéric Plantevin, MD
Phone 33 1 42 11 44 37
Email plantevin@igr.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Peri-Neuronal Catheter

Locations
Country Name City State
France Institut Gustave Roussy Villejuif

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess the influence of locoregional anesthesia on postoperative morphine consumption
Secondary Visual analog pain scale on the free flap donor site
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