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Perioperative intervention (preoperative acetaminophen, gabapentin, and celecoxib and intraoperative ketamine and lidocaine).

The Investigational Drug Service will mix and prepare the study medications necessary for each participant. An Investigational Drug Service staff member will deliver the oral medications to the nursing team in the preoperative holding unit and the IV medications to the anesthesia team in the OR unit.

Perioperative placebo

Placebo oral drugs will be encapsulated versions provided by the Investigational Drug Service and will appear identical to the interventional oral drugs. Placebo IV infusions will be prepared by Investigational Drug Service as per institutional guidelines and will appear identical to the interventional IV drugs.

0.25 mg/kg IV bolus before incision, followed by 0.005 mg/kg/minute IV for the remainder of the surgical case excluding the final 30-45 minutes.

Placebo Ketamine

1.5 mg/kg IV bolus before incision, followed by infusion of 1.5 mg/kg/hour ideal body weight (max 8 hours) during the case

Placebo Lidocaine

1,000 mg orally at time of check-in to the preoperative unit

Placebo Acetaminophen

600 mg orally at time of check in to the preoperative unit

Placebo Gabapentin

200 mg orally at time of check in to the preoperative unit

Placebo Celecoxib

Jamie Ku, MD

The purpose of this study is to determine how a non-opioid pain control regimen, administered before and during surgery, will affect postoperative pain control and total opioid consumption in head and neck cancer participants undergoing cancer surgery with free flap reconstruction.

This study will help the study team determine how the experimental, non-opioid pain control regimen affects opioid-related side effects, participant satisfaction with pain management, PACU length of stay, hospital length of stay, chronic pain level, and chronic pain-related disability in participants, and to determine the safety and tolerability of the non-opioid pain control regimen in head and neck cancer patients undergoing cancer surgery with free flap reconstruction. Ketamine, Lidocaine, Acetaminophen, Gabapentin, and Celecoxib are FDA-approved drugs that have been approved for use individually, and have been used in combination for perioperative pain control. However, the use of these five drugs together in head and neck cancer patients undergoing free flap reconstruction has not been studied, which is why this study is experimental.

Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery

Investigating the Effect of a Perioperative Analgesia Protocol on Postoperative Opioid Usage and Pain Control in Patients Undergoing Major Head and Neck Cancer Surgery Requiring Microvascular Free Flap Reconstruction

Total opioid consumption measured in daily morphine equivalent

Change in pain levels on Visual Analog Scale (VAS 0-100mm scale with higher scores corresponding to more pain)

Average Opioid Related Symptom Distress Scale (ORSDS) scores

The OR-SDS is used to assess subject-reported levels of severity concerning 12 symptoms known to be associated with opioid medication usage. Symptom frequency, severity, and how bothersome symptom was is rated from 1-4 with higher . The average score for each symptom is calculated by taking the mean of patient-reported score. Total possible severity score: 0 (less severe) to 4 (more severe).

Average scores for Internally-developed "patient satisfaction with pain management" questionnaire.

Domains include pain expected vs experienced, frequency of severe pain, promptness of care team, effectiveness of treatment, and future preferences

Domain scores range from 1-5 with higher scores mean worse outcomes (more severe pain, poor quality of care)

Domains are distinct and are not summarized with a "total"score.

Time to first flatulence and defecation from end of surgical case

Spots Global Cancer Trial Database for placebo gabapentin