Regional Block for Postoperative Free Flap Care
Study Details
Study Description
Brief Summary
The purpose of this protocol is to evaluate the safety and efficacy of regional anesthesia for head and neck patients undergoing microvascular free flap reconstruction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The increasing rate of opioid related overdose mortality is well documented in the literature and approached 15 per 100,000 in 2017. Because of a growing epidemic in the US, the medical community is under scrutiny to curtail opioid prescription. However, this is weighed against surgical outcomes; importantly, postoperative pain has adverse effects on function, recovery and quality of life.
Regional anesthesia provides a non opioid based, pain control strategy. First, regional anesthesia decreases systemic adverse events including respiratory failure in abdominal surgery, decreases length of stay and improves rehabilitation in common orthopedic procedures such as total knee arthroplasty and shoulder arthroplasty. Second, the physiologic benefits of regional anesthesia are compelling including augmented micro and macrocirculation, maintenance of body temperature and decreased systemic stress response through chemical sympathectomy. Finally, regional anesthesia has been established as safe in the microvascular and anesthesia literature for pediatric, and adult patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Group US-guided ipsilateral sciatic nerve block for fibula free flap patients utilizing ropivacaine 0.2% at 2-8 cc/hr for fibula free flap patients; US-guided infraclavicular brachial plexus nerve block for forearm free lap patients utilizing ropivacaine 0.2% at 2-8cc/hr for forearm free flap patients. |
Drug: ropivicaine 0.2%
2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.
Other Names:
|
| No Intervention: Control Group No regional anesthetic of any kind during the surgical procedure. |
Outcome Measures
Primary Outcome Measures
- Participant pain control [21 days]
Self-report of pain score on a scale of 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable"
Secondary Outcome Measures
- Opioid medication use [21 days]
Amount of opioid medication used post-operatively, based on pill count
Eligibility Criteria
Criteria
Inclusion criteria:
-
Age > 18
-
Able to consent for themselves
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Undergoing a head and neck surgery at UAB with reconstruction using either a forearm free flap or a fibula free flap
Exclusion criteria:
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Age < 18
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Unable to consent for themselves
-
Non-English speakers
-
Non-resectable tumor
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Have a known opioid tolerance, or are on a home opioid regimen for a chronic condition. (Short-term opioid use for diagnostic procedures (i.e. biopsy) or new cancer diagnosis will be allowed).
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Patients with known hepatic failure, renal failure, or sulfa allergy, as determined by standard of care labs drawn within 30 days of enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
- Principal Investigator: Anthony Morlandt, MD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-300003574