Pre-operative Education Modalities to Decrease Opioid Use
NCT ID: NCT04933084
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2021-09-16
2024-05-31
Brief Summary
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Detailed Description
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During their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider. The study group will receive additional standardized pre-operative education including the topics of:
1. Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP.
2. Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids.
3. Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction.
Patients in both usual care and study groups will receive standardized multimodal analgesia program with minimal opioids used.
Primary outcomes measured will include in-hospital and post-discharge opioid use, pain levels and time to return of bowel function. Secondary outcomes will include daily measures of patient satisfaction and quality of life, feeling of preparedness to manage post-operative pain, as well as incidence of prolonged opioid use at 90 days after surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Usual Care
During their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider.
No interventions assigned to this group
Text Handout
This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout.
Pre-operative Opioid Education
The pre-operative education in the text handout and pre-recorded video will include the topics of:
1. Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP.
2. Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids.
3. Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction.
Text handout and Pre-recorded Video
This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout AND pre-recorded video.
Pre-operative Opioid Education
The pre-operative education in the text handout and pre-recorded video will include the topics of:
1. Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP.
2. Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids.
3. Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction.
Interventions
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Pre-operative Opioid Education
The pre-operative education in the text handout and pre-recorded video will include the topics of:
1. Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP.
2. Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids.
3. Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction.
Eligibility Criteria
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Inclusion Criteria
* Undergoing RARP at VMMC
* Consent to participate in the study
Exclusion Criteria
* History of drug or alcohol dependence
* Concurrent surgery during radical prostatectomy
* History of allergy to opioid analgesics, NSAIDs, acetaminophen or local anesthetics
* Inability or unwillingness to give written informed consent
18 Years
MALE
Yes
Sponsors
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Benaroya Research Institute
OTHER
Responsible Party
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Una Lee
Staff Urologist
Principal Investigators
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Una Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Mason Medical Center
Locations
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Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Eyal Kord, MD
Role: primary
Debbie Sparks, CCRC
Role: backup
References
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Overview | Drug Overdose | CDC Injury Center. Published March 19, 2020. Accessed November 5, 2020. https://www.cdc.gov/drugoverdose/data/prescribing/overview.html
Lee DJ, Talwar R, Ding J, Chandrasekar T, Syed K, Fonshell C, Danella J, Ginzburg S, Lanchoney T, Tomaszewski J, Trabulsi E, Reese A, Smaldone M, Uzzo R, Raman JD, Guzzo TJ. Stakeholder Perspective on Opioid Stewardship After Prostatectomy: Evaluating Barriers and Facilitators From the Pennsylvania Urology Regional Collaborative. Urology. 2020 Nov;145:120-126. doi: 10.1016/j.urology.2020.05.096. Epub 2020 Jul 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.
Khorfan R, Shallcross ML, Yu B, Sanchez N, Parilla S, Coughlin JM, Johnson JK, Bilimoria KY, Stulberg JJ. Preoperative patient education and patient preparedness are associated with less postoperative use of opioids. Surgery. 2020 May;167(5):852-858. doi: 10.1016/j.surg.2020.01.002. Epub 2020 Feb 20.
Jacobs BL, Rogers D, Yabes JG, Bandari J, Ayyash OM, Maganty A, Armann KM, Worku HA, Pace NM, Shah A, Pekala KR, Yu M, Chelly JE, Macleod LC, Davies BJ. Large reduction in opioid prescribing by a multipronged behavioral intervention after major urologic surgery. Cancer. 2021 Jan 15;127(2):257-265. doi: 10.1002/cncr.33200. Epub 2020 Oct 1.
Alter TH, Ilyas AM. A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Carpal Tunnel Release Surgery. J Hand Surg Am. 2017 Oct;42(10):810-815. doi: 10.1016/j.jhsa.2017.07.003. Epub 2017 Sep 8.
Syed UAM, Aleem AW, Wowkanech C, Weekes D, Freedman M, Tjoumakaris F, Abboud JA, Austin LS. Neer Award 2018: the effect of preoperative education on opioid consumption in patients undergoing arthroscopic rotator cuff repair: a prospective, randomized clinical trial. J Shoulder Elbow Surg. 2018 Jun;27(6):962-967. doi: 10.1016/j.jse.2018.02.039. Epub 2018 Mar 26.
Sabesan VJ, Chatha K, Koen S, Dawoud M, Gilot G. Innovative patient education and pain management protocols to achieve opioid-free shoulder arthroplasty. JSES Int. 2020 May 4;4(2):362-365. doi: 10.1016/j.jseint.2020.01.005. eCollection 2020 Jun.
Farley KX, Anastasio AT, Kumar A, Premkumar A, Gottschalk MB, Xerogeanes J. Association Between Quantity of Opioids Prescribed After Surgery or Preoperative Opioid Use Education With Opioid Consumption. JAMA. 2019 Jun 25;321(24):2465-2467. doi: 10.1001/jama.2019.6125.
Parsa FD, Pavlosky KK, Harbison G, Yim N, Cheng J, Marison SR Jr, Parsa AA. Effect of Preoperative Patient Education on Opioid Consumption and Well-Being in Breast Augmentation. Plast Reconstr Surg. 2020 Feb;145(2):316e-323e. doi: 10.1097/PRS.0000000000006467.
Rucinski K, Cook JL. Effects of preoperative opioid education on postoperative opioid use and pain management in orthopaedics: A systematic review. J Orthop. 2020 Jan 21;20:154-159. doi: 10.1016/j.jor.2020.01.020. eCollection 2020 Jul-Aug.
Bohringer C, Astorga C, Liu H. The Benefits of Opioid Free Anesthesia and the Precautions Necessary When Employing It. Transl Perioper Pain Med. 2020;7(1):152-157.
Other Identifiers
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CRP20107
Identifier Type: -
Identifier Source: org_study_id