Clinical trial NCT04246697: Multimodal Pain Study in Free Flap Patients
Official title: Multimodal Management for Perioperative Analgesia in Otolaryngology - Head and Neck Free Flap Reconstructive Surgery: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Head and Neck Cancer
Analgesia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 .

Primary outcomes:
measure: Mean morphine equivalents for Arm A
timeFrame: During the study period of approximately 1 year
measure: Mean morphine equivalents for Arm B
timeFrame: During the study period of approximately 1 year
Secondary outcomes:
measure: Length of stay
timeFrame: Analyze the first 7 post-operative days but take note of how long they stayed.
measure: Post-operative complications
timeFrame: Analyze the first 7 post-operative days
measure: Pain assessment for patients
timeFrame: Nurses will use the DVPRS for each assessment while the patient is hospitalized, typically for seven days. Nursing assessments typically are Q2H-Q4H.
measure: Pain assessment for patients
timeFrame: The ABC pain scale will be given once daily for the patient to fill out for the first seven days.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: KUMC
name: Lisa Shnayder, MD
role: PRINCIPAL_INVESTIGATOR
References: