Recruiting
Phase 2
Phase 3

Opioid Free vs. Opioid

Sponsor:

University of South Florida

Code:

NCT03367988

Conditions

Analgesic Drug Dependence

Colectomy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Opioid Anesthesia

Opioid-free Anesthesia

Study Details

Brief summary:

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

Conditions

Analgesic Drug Dependence

Colectomy

Study ID

NCT03367988

Start date

Dec 1, 2018

Status verified date

May, 2022

Completion date

Aug, 2023

Anticipated

Primary completion date

Jan, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Opioid-free Anesthesia

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

active comparator: Opioid Anesthesia

Patients will receive intraoperative narcotics as part of their anesthesia regimen

Interventions

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.

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.

Primary outcome measure

  • Brief Pain Inventory [ Time Frame: Once a week for up to 12 months ]
  • Post-surgical opioid prescription use, # of pills used per week [ Time Frame: Once a week for up to 12 months ]

Central Contacts and Locations

Central contacts

Enrico M Camporesi, MD

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

Maha A Balouch, MA

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

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Enrico M Camporesi, MD

813-600-9094ecampore@health.usf.edu

Maha Balouch, BA

8138444116maha_balouch@teamhealth.com

More Information

Sponsor

University of South Florida

Last update posted

May 25, 2022

Last verified

May, 2022

Keywords

  • Opioid Dependence
  • Analagesia
  • Opioid-free Anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2022-05-25.