Opioid Consumption Clinical Trial
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
Verified date | October 2023 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | October 31, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total opioid consumption measured in daily morphine equivalent | Total opioid consumption measured in daily morphine equivalent | at 48 hours postop | |
Primary | 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) | Pre-Op, 24 hours postop, and 48 hours postop | |
Secondary | 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). |
at 96 hours after surgery, and at discharge (an average of 1 week) | |
Secondary | 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. |
at the time of discharge (an average of 1 week) | |
Secondary | Time to first flatulence and defecation | Time to first flatulence and defecation from end of surgical case | an average of 7 days |
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