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

May 23, 2022 updated by: University of South Florida

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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.
1 - 3 hours
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
1 - 3 hours
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
1 - 3 hours
Patient Satisfaction
Time Frame: 12 months
Patient treatment satisfaction survey results
12 months
Length of Stay
Time Frame: 1- 5 days
Total length of hospital stay in hours
1- 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

December 4, 2017

First Posted (Actual)

December 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00032413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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