Multimodal Pain Study in Free Flap Patients
Head and Neck Cancer, Analgesia
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients over the age of 18 who are seen in the Department of Otolaryngology-Head and Neck Surgery clinic.
- Patients with a new H&N cancer diagnosis undergoing primary surgery (free flap) for their cancer treatment.
Exclusion Criteria:
- Prior treatment for head and neck cancer.
- Planned treatment with primary radiation or chemoradiation for their head and neck cancer.
- Pregnant or lactating women.
- Patients with a history of consistent or regular opioid use for greater than six months used pre-operatively.
- Chronic gabapentin, pregabalin, and other non-opioid pain medication use pre-operatively.
- Diagnoses with fibromyalgia, anxiety disorder and other pain syndromes.
- Patients with documented history of kidney or liver disease.
- Patients with pre-operative lab values concerning for kidney/liver disease such as increased creatinine or liver function tests.
- Patients with a history of a serious GI bleed, CAD, or history of ischemic stroke .
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard of Care A
Standard of Care B
Randomized controlled prospective trial to compare two standards of care for head and neck surgery pain management. Arm A, will include: Scheduled Tylenol 1000 mg IV one time dose intra-operatively, then 650 mg via PEG tube or PO Q4H to a max dose of 4gm/24 hrs Opioids prn based on Numeric Pain Scale (0-10, with 0 indicating no pain and 10 indicating worst pain ever): 0-3: no prn meds, reassurance, listen to music, watch TV. 4-7: Oxycodone 5 mg q4h prn via PEG tube or PO with a maximum of 30 mg/24 hours. 8-10 Morphine 2 mg IV q2h prn breakthrough pain.
Arm B, will include: Arm A description with addition.. Scheduled Ketorolac starting post-op day #1, 15 mg q6h (max 120 mg/day), for a total of 5 days Scheduled Gabapentin starting 7 days preoperatively to continue postoperatively Regional block per anesthesia protocol - Initial block: 0.5% bupivacaine, 20 ml Continuous infusion: 0.125% bupivacaine at 6 ml/hr with a 5 ml bolus available every 30 mins