Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Women aged 18 or older.
• Patients with a French health insurance coverage (having a French social security number).
• Patient eligible for free flap reconstruction surgery of the breastunder general anaesthesia.
• Patient who has given written consent to participate in accordance with the regulations.
• Having a negative blood pregnancy test for patients of childbea ring age.
Locations
Other Locations
France
Institut Curie Paris
RECRUITING
Paris
Institut Curie Saint-Cloud
RECRUITING
Saint-cloud
Gustave Roussy, Cancer Campus, Grand Paris
RECRUITING
Villejuif
Contact Information
Primary
Anne-Claire COYNE, PhD
anne-claire.coyne@curie.fr
0033156245765
Backup
Mary SAAD, MD
mary.saad@curie.fr
0033147112371
Time Frame
Start Date: 2022-12-07
Estimated Completion Date: 2027-06-06
Participants
Target number of participants: 158
Treatments
Experimental: OFA group
OFA (Opioid Free Anaesthesia) group:
No_intervention: CA control group
CA (Conventional Anaesthesia) control group:
Authors
ACIKGOZ Hans
Related Therapeutic Areas
Sponsors
Leads: Institut Curie