Opioid Free Anesthesia vs. Opioid Anesthesia Techniques.

NCT03367988 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: Pro00032413
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Analgesic Drug Dependence; Colectomy

Keywords

Opioid Dependence; Analagesia; Opioid-free Anesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• PACU: Pain Scores

  1 - 3 hours

• PACU: Nausea Scores

  1 - 3 hours

• PACU: Opioid Use in Morphine Equivalents

  1 - 3 hours

• Patient Satisfaction

  12 months

• Length of Stay

  1- 5 days

Study Arms (2)

Opioid-free Anesthesia

EXPERIMENTAL

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

Drug: Opioid-free Anesthesia

Opioid Anesthesia

ACTIVE COMPARATOR

Patients will receive intraoperative narcotics as part of their anesthesia regimen

Drug: Opioid Anesthesia

Interventions

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 Anesthesia

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.

Opioid-free Anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to TGH for laparoscopic colectomy under Dr. Sanchez's care
• Adults aged 18 and older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 28033313 BACKGROUND

• 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.

  PMID: 26977696 BACKGROUND

• 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.

  PMID: 22729963 BACKGROUND

• 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.

  PMID: 28403427 BACKGROUND

• 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. No abstract available.

  PMID: 27429023 BACKGROUND

• Kharasch ED, Brunt LM. Perioperative Opioids and Public Health. Anesthesiology. 2016 Apr;124(4):960-5. doi: 10.1097/ALN.0000000000001012. No abstract available.

  PMID: 26808634 BACKGROUND

• 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.

  PMID: 26655493 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Enrico Camporesi, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico M Camporesi, MD

CONTACT

(813) 600-9094; ecampore@health.usf.edu

Maha A Balouch, MA

CONTACT

(813) 844-4071; mbalouch@mail.usf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blinded: Study participants will not know what form of anesthesia they are being given.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: December 11, 2017
• Study Start: December 1, 2018
• Primary Completion: January 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)