Opioid Free Anesthesia vs. Opioid Anesthesia Techniques.

Study Overview
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Brief Summary
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A comparison of post-operative opioid use in Laparoscopic Colectomy patients receiving Opioid or Opioid-free Anesthesia.

Detailed Description
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The study population will be composed of 100 patients total, 50 opioid-free anesthesia laparoscopic colectomy patients and 50 opioid anesthesia laparoscopic colectomy patients at Tampa General Hospital. After consent is obtained patients will be electronically randomized using REDCap in a 1:1 ratio and assigned to a opioid anesthesia or opioid free anesthesia group. Patients will also consent to be asked survey questions preoperatively and be followed for 12 months postoperatively at specific intervals to evaluate pain, satisfaction, and opioid prescription use. This will be done through a data mining platform and service known as REDCap. REDCap is partnered with USF to allow for subject management, data collection and the distribution of surveys via mobile phone. All data collected by REDCap is stored on a HIPPA compliant server. Patients will receive automated push notifications to their mobile phones to fill out surveys regarding their pill usage, pain, and satisfaction for a year or until cessation of opioid use is confirmed. Confirmation of opioid cessation will be performed on a case by case basis by the principal investigator, Dr. Camporesi. In addition to the surveys performed, nausea and pain scores will be collected prospectively from observation in the PACU

Official Title
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Effect of Intraoperative and Post-operative Opioids on Persistent Opioid Use in the Surgical Patient

Conditions
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Analgesic Drug Dependence, Colectomy

Intervention / Treatment
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* Drug: Opioid Anesthesia
* Drug: Opioid-free Anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to TGH for laparoscopic colectomy under Dr. Sanchez's care Adults aged 18 and older Exclusion Criteria: Patients who are pregnant Patients that are not registered within Tampa General Hospital Electronic Medical Records System Patients without smart phone capabilities Patients younger than 18 years Patients older than 80 years Patients who cannot speak or read English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid-free Anesthesia<br>Patients will receive no intraoperative narcotics as part of their anesthesia regimen | Drug: Opioid-free Anesthesia<br>* Doses/concentration of medications/agents used for the anesthetic management of the subjects enrolled in this trial may be adjusted when necessary to provide optimal subject care. Acetaminophen 1g will be given prior to induction. Anesthesia will be induced with rocuronium 1mg, propofol 3-6 mg/kg, and succinylcholine 1.5 mg/kg Depth of anesthesia will be measured with BIS-monitoring and a standard approaching 50% suppression will be maintained throughout the main duration of surgery. Reversal agent will be administered at a post-tetanic count of 1 or 2. Anesthesia will be maintained with Sevoflurane, Magnesium, Lidocaine, Ketamine, Decadron, Ondansetron, and Ketorolac at a concentration range/dose(s) based on the clinical need of the subject. Tracheal extubation will be performed at the end of anesthesia after administration of reversal agent. After extubation, the investigator will determine when the subject is OR discharge ready.<br>|
| Active Comparator: Opioid Anesthesia<br>Patients will receive intraoperative narcotics as part of their anesthesia regimen | Drug: Opioid Anesthesia<br>* Doses/concentration of medications/agents used for the anesthetic management of the subjects enrolled in this trial may be adjusted when necessary to provide optimal subject care. Anesthesia will be induced with rocuronium, propofol, intravenous opioids, and other medication(s)/agent(s) at a concentration range/dose(s) based on the clinical need of the subject. Depth of anesthesia will be measured with BIS-monitoring and a standard approaching 50% suppression will be maintained throughout the main duration of surgery. Reversal agent will be administered at a post-tetanic count of 1 or 2. Anesthesia will be maintained with IV opioids, propofol and/or medication(s)/agent(s), including inhalation anesthetic agents, at a concentration range/dose(s) based on the clinical need of the subject. Tracheal extubation will be performed at the end of anesthesia after administration of reversal agent. After extubation, the investigator will determine when the subject is OR discharge ready.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory | a standardized 9 question survey broken into pain severity and pain interference sections. The sections rank various items relating to their respective categorizations of pain on a scale from 0 to 10. The arithmetic mean of each section can then be utilized to determine Severity of pain and impact of pain on daily function during the past week. | Once a week for up to 12 months | 
| Post-surgical opioid prescription use, # of pills used per week | Weekly pill use for pain management upon discharge | Once a week for up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PACU: Pain Scores | Visual Analogue Scale (VAS) pain scores every 15 minutes on a 10 centimeter scale. Using a ruler, the score is determined by measuring the distance (cm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity. no pain (0 cm), mild pain(1-4.4 cm), moderate pain (4.5-7.4 cm), and severe pain (7.5-10 cm). Normative values are not available. The scale has to be shown to the patient otherwise it is an auditory scale not a visual one. | 1 - 3 hours | 
| PACU: Nausea Scores | Postoperative Nausea and Vomiting (PONV) every 15 minutes scores (0-4) 0, no nausea; 1, mild nausea ≤ 15 minutes; 2, nausea ≥ 10 minutes; 3, nausea ≥ 5 minutes; 4, vomiting | 1 - 3 hours | 
| PACU: Opioid Use in Morphine Equivalents | Total ammount of rescue narcotics used in PACU converted to milligram morphine equivalents using CDC guidelines for prescribing Opioids | 1 - 3 hours | 
| Patient Satisfaction | Patient treatment satisfaction survey results | 12 months | 
| Length of Stay | Total length of hospital stay in hours | 1- 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid Dependence, Analagesia, Opioid-free Anesthesia