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ProstatectomyNCT04933084

Pre-operative Education Modalities to Decrease Opioid Use

A study testing Pre-operative Opioid Education in people with Prostatectomy and Opioid-Related Disorders, run by Benaroya Research Institute at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a triple-armed, randomized, controlled, non-blinded trial to study the effect of preoperative patient education in conjunction with a limited opioid peri-operative analgesia program on post-operative opioid use following radical prostatectomy. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Prostatectomy, Opioid-Related Disorders
What is being tested?
Pre-operative Opioid Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
16 Sep 2021to May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age > 18
  • Undergoing RARP at VMMC
  • Consent to participate in the study

Who cannot join

  • Long-term opioid use defined as use of opioids on most days for >3 months
  • 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

Trial locations and contacts

1 site in 1 country.

Eyal Kord, MD contact

206-223-6772

Eyal.Kord@virginiamason.org

United States1 site, 1 recruiting

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Eyal Kord, MD, 206-223-6772, Eyal.Kord@virginiamason.org

    Debbie Sparks, CCRC, 206-341-0896, Deborah.Sparks@virginiamason.org

    Recruiting

Other trials in United States

About this study

Official title: Evaluation of Pre-operative Education Modalities to Decrease Opioid Use in Prostate Cancer Patients: A Prospective Randomized Control Trial

This is a triple-armed, randomized, controlled, non-blinded trial to study the effect of preoperative patient education in conjunction with a limited opioid peri-operative analgesia program on post-operative opioid use following radical prostatectomy. Patients will be randomized into three education arms: usual care (variable provider-dependent education), text handout, or text handout and pre-recorded video. The impact of patient education on outcomes of in-hospital, post-discharge, and persistent opioid use will be studied.

Read the detailed description

This is a triple-armed, randomized, controlled, non-blinded trial that will be conducted at Virginia Mason Medical Center (VMMC). Men of age 18 or older undergoing robotic assisted radical prostatectomy (RARP) for prostate cancer will be approached to participate in the study. Recruited patients will be randomized into three main groups based upon opioid education given to the patient before surgery: usual care group, text handout group, and text handout with pre-recorded video group.

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.

Being tested
Pre-operative Opioid Education
Keywords
Opioid Education, Post-operative Opioid Use
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-operative Opioid EducationBehavioural

    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.
Study groups in NCT04933084
Study groupRoleWhat they receive
Usual CareNo interventionDuring their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider.
Text HandoutExperimentalThis group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout.
Receives: Behavioral: Pre-operative Opioid Education
Text handout and Pre-recorded VideoExperimentalThis group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout AND pre-recorded video.
Receives: Behavioral: Pre-operative Opioid Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital opioid use

    Morphine equivalents used in the hospital will be calculated.

    Measured: Immediately after the intervention/procedure/surgery

  2. Post-discharge opioid use

    Patient-reported number of opioid pills used after discharge (daily questionnaire).

    Measured: Immediately after the intervention/procedure/surgery

  3. Post-operative pain

    Average pain over the course of today. (0=no pain, 5=moderate pain, 10=severe pain)

    Measured: Immediately after the intervention/procedure/surgery

  4. Return of bowel function

    Patient-reported return of bowel function as time in days to first flatus and first bowel movement.

    Measured: Immediately after the intervention/procedure/surgery

Secondary outcomes (3)

  1. Satisfaction with undergoing the surgery

    Satisfaction with undergoing the surgery. (1=extremely dissatisfied, 10=extremely satisfied)

    Measured: Immediately after the intervention/procedure/surgery

  2. Quality of life after undergoing surgery

    Quality of life after the surgery. (1=worst possible QOL, 10=best possible QOL)

    Measured: Immediately after the intervention/procedure/surgery

  3. Prolonged post-operative opioid use

    Incidence of prolonged postoperative opioid use defined by the American Society of Interventional Pain Physicians Guidelines as continued use beyond the normal and expected time of 90 days for surgical healing.

    Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2021
  2. Study start16 Sep 2021
  3. Primary completionMay 2024 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Triple-armed randomized control trial
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04933084
Sponsor's protocol ID
CRP20107
Status last verified
Dec 2023
First submitted
11 Jun 2021
Last updated
21 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32711014

  • 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.

    PubMed 28403427

  • 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.

    PubMed 32087946

  • 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.

    PubMed 33002197

  • 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.

    PubMed 28890331

  • 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.

    PubMed 29599038

  • 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.

    PubMed 32490427

  • 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.

    PubMed 31237629

  • 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.

    PubMed 31985627

  • 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.

    PubMed 32025140

  • 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.

    PubMed 31712783

Questions about this trial

What is this clinical trial studying?

A study testing Pre-operative Opioid Education in people with Prostatectomy and Opioid-Related Disorders, run by Benaroya Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eyal Kord, MD (206-223-6772, Eyal.Kord@virginiamason.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital opioid use (time frame: Immediately after the intervention/procedure/surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04933084, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.

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