Opioid Free Anesthesia vs. Opioid Anesthesia Techniques.

Ketamine

Brief Summary

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

Intervention / Treatment

Randomized Controlled Trial
  • Opioid Anesthesia (DRUG)
    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.
  • Opioid-free Anesthesia (DRUG)
    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.

Condition or Disease

  • Analgesic Drug Dependence
  • Colectomy

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 18 Years to 80 Years
    Enrollment: 100 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    Single Blinded: Study participants will not know what form of anesthesia they are being given.

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Dec 01, 2018 ACTUAL
    Primary Completion: Jan 01, 2023 ESTIMATED
    Completion Date: Aug 01, 2023 ESTIMATED
    Study First Posted: Dec 11, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: May 23, 2022

    Sponsors / Collaborators

    Lead Sponsor: University of South Florida
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Tampa, Florida, USA

    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

    Participant Groups

    • Patients will receive no intraoperative narcotics as part of their anesthesia regimen

    • Patients will receive intraoperative narcotics as part of their anesthesia regimen

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 80
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • 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.

    • Weekly pill use for pain management upon discharge

    Secondary Outcomes

    • 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.

    • 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

    • Total ammount of rescue narcotics used in PACU converted to milligram morphine equivalents using CDC guidelines for prescribing Opioids

    • Patient treatment satisfaction survey results

    • Total length of hospital stay in hours

    More Details

    NCT Number: NCT03367988
    Acronym: OFA vs OA
    Other IDs: Pro00032413
    Study URL: https://clinicaltrials.gov/study/NCT03367988
    Last updated: Sep 29, 2023