Status:
COMPLETED
Local Infusion of Ropivacaine for Post-Op Pain Control After Osseocutaneous Free Flaps
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Head and Neck Cancer
Free Tissue Transfer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Head and neck oncologic surgery often requires the use of free tissue transfer, or microvascular reconstruction, to reconstruct defects created by tumor resections. Although there are several techniqu...
Detailed Description
Procedures involved in this study include: \- Intraoperatively, following procurement of the fibula or scapula bone graft and at the time of surgical wound closure, all patients will receive the plac...
Eligibility Criteria
Inclusion
- Patients receiving osseocutaneous free tissue transfer regardless of the indication for free tissue transfer.
- This includes osseocutaneous tissue from fibula and scapula
- Age ≥ 18
Exclusion
- Patients unable to understand the research protocol and/or provide informed consent
- Patients under the age of 18
- Patients with a history of allergic reaction to Ropivacaine or other local amide anesthetics
- Patients whose participation in this trial would require exclusion from participation in another clinical research trial related to the patient's malignant diagnosis.
- Patients with previous pain disorders or drug abuse requiring chronic narcotic use.
- Vulnerable populations (adults unable to consent, individuals who are not yet adults, wards of the state, prisoners)
Key Trial Info
Start Date :
September 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03349034
Start Date
September 13 2017
End Date
September 30 2019
Last Update
November 17 2020
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10129