Opiod Free Anesthesia vs. Opioid Anesthesia Techniques. (OFA vs OA)

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ClinicalTrials.gov Identifier: NCT03367988

Recruitment Status : Recruiting

First Posted : December 11, 2017

Last Update Posted : October 23, 2020

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Sponsor:

Information provided by (Responsible Party):

University of South Florida

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Analgesic Drug Dependence Colectomy	Drug: Opioid Anesthesia Drug: Opioid-free Anesthesia	Phase 2 Phase 3

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Randomized Controlled Trial
Masking:	Single (Participant)
Masking Description:	Single Blinded: Study participants will not know what form of anesthesia they are being given.
Primary Purpose:	Prevention
Official Title:	Effect of Intraoperative and Post-operative Opioids on Persistent Opioid Use in the Surgical Patient
Actual Study Start Date :	December 1, 2018
Estimated Primary Completion Date :	January 2021
Estimated Study Completion Date :	January 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Opioid addiction

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Opioid-free Anesthesia Patients will receive no intraoperative narcotics as part of their anesthesia regimen	Drug: Opioid-free Anesthesia 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.
Active Comparator: Opioid Anesthesia Patients will receive intraoperative narcotics as part of their anesthesia regimen	Drug: Opioid Anesthesia 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.

Arm

Intervention/treatment

Experimental: Opioid-free Anesthesia

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

Drug: Opioid-free Anesthesia

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.

Active Comparator: Opioid Anesthesia

Patients will receive intraoperative narcotics as part of their anesthesia regimen

Drug: Opioid Anesthesia

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.

Outcome Measures

Primary Outcome Measures :

Brief Pain Inventory [ Time Frame: Once a week for up to 12 months ]
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.
Post-surgical opioid prescription use, # of pills used per week [ Time Frame: Once a week for up to 12 months ]
Weekly pill use for pain management upon discharge

Secondary Outcome Measures :

PACU: Pain Scores [ Time Frame: 1 - 3 hours ]
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.
PACU: Nausea Scores [ Time Frame: 1 - 3 hours ]
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
PACU: Opioid Use in Morphine Equivalents [ Time Frame: 1 - 3 hours ]
Total ammount of rescue narcotics used in PACU converted to milligram morphine equivalents using CDC guidelines for prescribing Opioids
Patient Satisfaction [ Time Frame: 12 months ]
Patient treatment satisfaction survey results
Length of Stay [ Time Frame: 1- 5 days ]
Total length of hospital stay in hours

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367988

Contacts

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Contact: Enrico M Camporesi, MD	(813) 600-9094	ecampore@health.usf.edu
Contact: Maha A Balouch, MA	(813) 844-4071	mbalouch@mail.usf.edu

Locations

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United States, Florida
Tampa General Hospital	Recruiting
Tampa, Florida, United States, 33606
Contact: Enrico M Camporesi, MD 813-600-9094 ecampore@health.usf.edu
Contact: Maha Balouch, BA 8138444116 maha_balouch@teamhealth.com

Sponsors and Collaborators

University of South Florida

Investigators

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Principal Investigator:	Enrico Camporesi, MD	University of South Florida

Study Documents (Full-Text)

Documents provided by University of South Florida:

Informed Consent Form [PDF] July 11, 2017

Study Protocol [PDF] July 11, 2017

More Information

Publications:

Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.

Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464. Review.

Carroll I, Barelka P, Wang CK, Wang BM, Gillespie MJ, McCue R, Younger JW, Trafton J, Humphreys K, Goodman SB, Dirbas F, Whyte RI, Donington JS, Cannon WB, Mackey SC. A pilot cohort study of the determinants of longitudinal opioid use after surgery. Anesth Analg. 2012 Sep;115(3):694-702. doi: 10.1213/ANE.0b013e31825c049f. Epub 2012 Jun 22.

Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. Erratum in: JAMA Surg. 2019 Mar 1;154(3):272.

Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904.

Kharasch ED, Brunt LM. Perioperative Opioids and Public Health. Anesthesiology. 2016 Apr;124(4):960-5. doi: 10.1097/ALN.0000000000001012. Review.

Mauermann E, Filitz J, Dolder P, Rentsch KM, Bandschapp O, Ruppen W. Does Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?: A Double-blind, Randomized, Crossover Trial. Anesthesiology. 2016 Feb;124(2):453-63. doi: 10.1097/ALN.0000000000000976.

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Responsible Party:	University of South Florida
ClinicalTrials.gov Identifier:	NCT03367988
Other Study ID Numbers:	Pro00032413
First Posted:	December 11, 2017 Key Record Dates
Last Update Posted:	October 23, 2020
Last Verified:	September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Keywords provided by University of South Florida:


Opioid Dependence Analagesia Opioid-free Anesthesia

Additional relevant MeSH terms:

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Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Analgesics, Opioid Anesthetics Central Nervous System Depressants	Physiological Effects of Drugs Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents

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