Opioid Free Anesthesia vs. Opioid Anesthesia Techniques. (OFA vs OA)
Primary Purpose
Analgesic Drug Dependence, Colectomy
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Opioid Anesthesia
Opioid-free Anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Analgesic Drug Dependence focused on measuring Opioid Dependence, Analagesia, Opioid-free Anesthesia
Eligibility 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
Sites / Locations
- Tampa General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Opioid-free Anesthesia
Opioid Anesthesia
Arm Description
Patients will receive no intraoperative narcotics as part of their anesthesia regimen
Patients will receive intraoperative narcotics as part of their anesthesia regimen
Outcomes
Primary Outcome Measures
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.
Post-surgical opioid prescription use, # of pills used per week
Weekly pill use for pain management upon discharge
Secondary Outcome Measures
PACU: Pain Scores
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
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
Total ammount of rescue narcotics used in PACU converted to milligram morphine equivalents using CDC guidelines for prescribing Opioids
Patient Satisfaction
Patient treatment satisfaction survey results
Length of Stay
Total length of hospital stay in hours
Full Information
NCT ID
NCT03367988
First Posted
October 25, 2017
Last Updated
May 23, 2022
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT03367988
Brief Title
Opioid Free Anesthesia vs. Opioid Anesthesia Techniques.
Acronym
OFA vs OA
Official Title
Effect of Intraoperative and Post-operative Opioids on Persistent Opioid Use in the Surgical Patient
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A comparison of post-operative opioid use in Laparoscopic Colectomy patients receiving Opioid or Opioid-free Anesthesia.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesic Drug Dependence, Colectomy
Keywords
Opioid Dependence, Analagesia, Opioid-free Anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Participant
Masking Description
Single Blinded: Study participants will not know what form of anesthesia they are being given.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Opioid-free Anesthesia
Arm Type
Experimental
Arm Description
Patients will receive no intraoperative narcotics as part of their anesthesia regimen
Arm Title
Opioid Anesthesia
Arm Type
Active Comparator
Arm Description
Patients will receive intraoperative narcotics as part of their anesthesia regimen
Intervention Type
Drug
Intervention Name(s)
Opioid Anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Opioid-free Anesthesia
Intervention Description
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 Information:
Title
Brief Pain Inventory
Description
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.
Time Frame
Once a week for up to 12 months
Title
Post-surgical opioid prescription use, # of pills used per week
Description
Weekly pill use for pain management upon discharge
Time Frame
Once a week for up to 12 months
Secondary Outcome Measure Information:
Title
PACU: Pain Scores
Description
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.
Time Frame
1 - 3 hours
Title
PACU: Nausea Scores
Description
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
Time Frame
1 - 3 hours
Title
PACU: Opioid Use in Morphine Equivalents
Description
Total ammount of rescue narcotics used in PACU converted to milligram morphine equivalents using CDC guidelines for prescribing Opioids
Time Frame
1 - 3 hours
Title
Patient Satisfaction
Description
Patient treatment satisfaction survey results
Time Frame
12 months
Title
Length of Stay
Description
Total length of hospital stay in hours
Time Frame
1- 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enrico M Camporesi, MD
Phone
(813) 600-9094
Email
ecampore@health.usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maha A Balouch, MA
Phone
(813) 844-4071
Email
mbalouch@mail.usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrico Camporesi, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrico M Camporesi, MD
Phone
813-600-9094
Email
ecampore@health.usf.edu
First Name & Middle Initial & Last Name & Degree
Maha Balouch, BA
Phone
8138444116
Email
maha_balouch@teamhealth.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28033313
Citation
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.
Results Reference
background
PubMed Identifier
26977696
Citation
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.
Results Reference
background
PubMed Identifier
22729963
Citation
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.
Results Reference
background
PubMed Identifier
28403427
Citation
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.
Results Reference
background
PubMed Identifier
27429023
Citation
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.
Results Reference
background
PubMed Identifier
26808634
Citation
Kharasch ED, Brunt LM. Perioperative Opioids and Public Health. Anesthesiology. 2016 Apr;124(4):960-5. doi: 10.1097/ALN.0000000000001012. No abstract available.
Results Reference
background
PubMed Identifier
26655493
Citation
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.
Results Reference
background
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Opioid Free Anesthesia vs. Opioid Anesthesia Techniques.
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