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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
30
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.
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.
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
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Total opioid consumption measured in daily morphine equivalent
Total opioid consumption measured in daily morphine equivalent
Time frame: at 48 hours postop
Pain levels on Visual Analog Scale (VAS)
Change in pain levels on Visual Analog Scale (VAS 0-100mm scale with higher scores corresponding to more pain)
Time frame: Pre-Op, 24 hours postop, and 48 hours postop
Average Opioid Related Symptom Distress Scale (ORSDS) scores
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).
Time frame: at 96 hours after surgery, and at discharge (an average of 1 week)
Average Patient satisfaction with pain management scores
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 frame: at the time of discharge (an average of 1 week)
Time to first flatulence and defecation
Time to first flatulence and defecation from end of surgical case
Time frame: an average of 7 days
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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
1,000 mg orally at time of check-in to the preoperative unit
1,000 mg orally at time of check-in to the preoperative unit
600 mg orally at time of check in to the preoperative unit
600 mg orally at time of check in to the preoperative unit
200 mg orally at time of check in to the preoperative unit
200 mg orally at time of check in to the preoperative unit