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

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00181038
• Collaborator: (none)
• Enrollment: 40
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Oropharyngeal Neoplasms	Device: Peri-Neuronal Catheter	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: Jun 1, 2004

Outcome Measures

Primary Outcome Measures

1. Assess the influence of locoregional anesthesia on postoperative morphine consumption []

Secondary Outcome Measures

1. Visual analog pain scale on the free flap donor site []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Gustave Roussy	Villejuif		France	94800

Sponsors and Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00181038
• Other Study ID Numbers: PERONE; CSET 2003/1042
• First Posted: Sep 16, 2005
• Last Update Posted: Aug 28, 2007
• Last Verified: Sep 1, 2006

• Keywords provided by , ,: Oro-Pharyngeal Carcinoma Surgery
• Additional relevant MeSH terms: Carcinoma; Oropharyngeal Neoplasms

Study Results

No Results Posted as of Aug 28, 2007