Head and Neck Cancer, Analgesia
Conditions
Brief summary
This study will be fashioned as a randomized, prospective study comparing Pain Management Arm A and Pain Management Arm B. Arm A will have scheduled Tylenol with opioids available as needed (PRN) in the peri-operative period. Arm B will undergo scheduled Gabapentin, Ketorolac and Tylenol as well as the Anesthesiology team managing regional nerve blocks, with opioids available PRN in the peri-operative period. The amount of pain medication used by all patients will be recorded as well as pain scores documented on a pain scale (0-10 with 0 indicating no pain and 10 indicating worst pain ever) as well as ABC pain scale throughout the patients' hospital stay. Morphine equivalents for the opioids will be calculated for each arm while observing pain scores. Then, the investigators will compare these two groups to see if there is a difference in opioid pain medication used. The study team's hypothesis is that the use of Gabapentin, Ketorolac, and Tylenol in combination will significantly reduce (at least 30% of Mean Morphine Equivalents - MME) the use of opioid medication for patients undergoing head and neck free flap reconstruction with similar to improved pain scores.
Interventions
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean morphine equivalents for Arm A | During the study period of approximately 1 year | Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them. |
| Mean morphine equivalents for Arm B | During the study period of approximately 1 year | Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | Analyze the first 7 post-operative days but take note of how long they stayed. | Length of stay in days |
| Post-operative complications | Analyze the first 7 post-operative days | Monitor chart/EMR for bleeding, acute kidney injury, etc. |
| Pain assessment for patients | Nurses will use the DVPRS for each assessment while the patient is hospitalized, typically for seven days. Nursing assessments typically are Q2H-Q4H. | Pain assessment will occur with nurses providing patient a 0-10 pain scale (i.e. 0 being the lowest and 10 being the greatest amount of pain) named the Defense Veterans Pain Rating Scale for each nursing assessment in order to know which pain medications to administer. |
Countries
United States
Outcome results
None listed