Regional Anesthesia for Head and Neck Reconstruction
Status and phase
Withdrawn
Phase 4
Conditions
Pain, Postoperative
Treatments
Drug: Regional Anesthesia
Details and patient eligibility
About
By utilizing regional anesthesia blocks at the surgery tissue donor sites, it can potentially reduce post-operative pain while also reducing the use of opioids. It can aim to measure the reduction in opioid use, reduction in pain scores, patient satisfaction, and because there is not a current protocol established for regional anesthesia use for free flap reconstruction, and we aim to standardize the procedure.
Sex
All
Ages
18 to 90 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Subjects undergoing microvascular fibula free flap reconstruction of the head and neck
- Subjects undergoing primary reconstruction for both benign and malignant etiology
Exclusion criteria
- Pregnant women
- Subjects with true allergies to the study drugs, reporting anaphylaxis in the past
- Subjects undergoing reconstruction with more than 1 free flap
- Subjects undergoing secondary reconstructions
- Subjects undergoing surgery for osteonecrosis
- History of enrollment in a pain management program
- Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
0 participants in 6 patient groups
Fibular free flap-Block performed
Active Comparator group
Description:
For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed
Treatment:
Drug: Regional Anesthesia
Anterolateral thigh free flap-Block performed
Active Comparator group
Description:
Description: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed
Treatment:
Drug: Regional Anesthesia
Radial forearm free flap-Block performed
Active Comparator group
Description:
Description: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed
Treatment:
Drug: Regional Anesthesia
Fibular free flap -Control
No Intervention group
Description:
No additional procedures beyond the normal standard of care will be performed
Anterolateral thigh free flap-Control
No Intervention group
Description:
No additional procedures beyond the normal standard of care will be performed
Radial forearm free flap-Control
No Intervention group
Description:
No additional procedures beyond the normal standard of care will be performed
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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