Postoperative Pain Control, Opioid Consumption
Conditions
Keywords
Head & neck cancer, Microvascular free flap reconstruction
Brief summary
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.
Detailed description
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.
Interventions
DRUGKetamine
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.
DRUGPlacebo Ketamine
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.
DRUGLidocaine
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
DRUGPlacebo Lidocaine
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
DRUGAcetaminophen
1,000 mg orally at time of check-in to the preoperative unit
DRUGPlacebo Acetaminophen
1,000 mg orally at time of check-in to the preoperative unit
DRUGGabapentin
600 mg orally at time of check in to the preoperative unit
600 mg orally at time of check in to the preoperative unit
DRUGCelecoxib
200 mg orally at time of check in to the preoperative unit
DRUGPlacebo Celecoxib
200 mg orally at time of check in to the preoperative unit
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing head & neck free flap reconstruction at the Cleveland Clinic Main Campus * Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* History of allergy to lidocaine, ketamine, acetaminophen, gabapentin, and/or celecoxib * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ketamine, Lidocaine or other agents used in this study * Subjects receiving any other investigational agents * Inadequate renal function (serum creatinine ≥ 2 mg/dl) within 30 days * Inadequate hepatic function (total bilirubin ≥ 2 x the institutional ULN and/or AST or ALT ≥3 x the institutional ULN) within 30 days * Known or suspected history of illicit drug abuse (including opioids but excluding tobacco and EtOH) within the past 6 months * Pregnancy * Contraindication to lidocaine (heart block, heart failure with EF \< 30%) as determined by history of Congestive Heart Failure, or as determined by preoperative evaluation for surgical clearance * In the opinion of the investigator, subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption measured in daily morphine equivalent | at 48 hours postop | Total opioid consumption measured in daily morphine equivalent |
| Pain levels on Visual Analog Scale (VAS) | Pre-Op, 24 hours postop, and 48 hours postop | Change in pain levels on Visual Analog Scale (VAS 0-100mm scale with higher scores corresponding to more pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Opioid Related Symptom Distress Scale (ORSDS) scores | at 96 hours after surgery, and at discharge (an average of 1 week) | 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 Patient satisfaction with pain management scores | at the time of discharge (an average of 1 week) | 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 totalscore. |
| Time to first flatulence and defecation | an average of 7 days | Time to first flatulence and defecation from end of surgical case |
Countries
United States
Outcome results
None listed