Clinical trial NCT04176419: Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Postoperative Pain Control
Opioid Consumption
Keywords: Head & neck cancer
Microvascular free flap reconstruction
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total opioid consumption measured in daily morphine equivalent
timeFrame: at 48 hours postop
measure: Pain levels on Visual Analog Scale (VAS)
timeFrame: Pre-Op, 24 hours postop, and 48 hours postop
Secondary outcomes:
measure: Average Opioid Related Symptom Distress Scale (ORSDS) scores
timeFrame: at 96 hours after surgery, and at discharge (an average of 1 week)
measure: Average Patient satisfaction with pain management scores
timeFrame: at the time of discharge (an average of 1 week)
measure: Time to first flatulence and defecation
timeFrame: an average of 7 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Jamie Ku, MD
role: PRINCIPAL_INVESTIGATOR
References: