Pre-operative Education Modalities to Decrease Opioid Use

NCT04933084 | Unknown

• 1 other identifier: CRP20107
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostatectomy; Opioid-Related Disorders

Keywords

Opioid Education; Post-operative Opioid Use

Outcome Measures

Primary Outcomes (4)

• In-hospital opioid use

  Morphine equivalents used in the hospital will be calculated.

  Immediately after the intervention/procedure/surgery

• Post-discharge opioid use

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

  Immediately after the intervention/procedure/surgery

• Post-operative pain

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

  Immediately after the intervention/procedure/surgery

• Return of bowel function

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

  Immediately after the intervention/procedure/surgery

Secondary Outcomes (3)

• Satisfaction with undergoing the surgery

  Immediately after the intervention/procedure/surgery

• Quality of life after undergoing surgery

  Immediately after the intervention/procedure/surgery

• Prolonged post-operative opioid use

  Up to 24 weeks

Study Arms (3)

Usual Care

NO INTERVENTION

During their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider.

Text Handout

EXPERIMENTAL

This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout.

Behavioral: Pre-operative Opioid Education

Text handout and Pre-recorded Video

EXPERIMENTAL

This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout AND pre-recorded video.

Behavioral: Pre-operative Opioid Education

Interventions

Pre-operative Opioid Education BEHAVIORAL

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; Text handout and Pre-recorded Video

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benaroya Research Institute: lead

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

Related Publications (12)

• Overview | Drug Overdose | CDC Injury Center. Published March 19, 2020. Accessed November 5, 2020. https://www.cdc.gov/drugoverdose/data/prescribing/overview.html

  BACKGROUND

• 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.

  PMID: 32711014 BACKGROUND

• 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.

  PMID: 28403427 BACKGROUND

• 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.

  PMID: 32087946 BACKGROUND

• 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.

  PMID: 33002197 BACKGROUND

• 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.

  PMID: 28890331 BACKGROUND

• 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.

  PMID: 29599038 BACKGROUND

• 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.

  PMID: 32490427 BACKGROUND

• 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.

  PMID: 31237629 BACKGROUND

• 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.

  PMID: 31985627 BACKGROUND

• 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.

  PMID: 32025140 BACKGROUND

• 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.

  PMID: 31712783 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Una Lee, MD

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyal Kord, MD

CONTACT

206-223-6772; Eyal.Kord@virginiamason.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Urologist

Model Details: Triple-armed randomized control trial

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 21, 2021
• Study Start: September 16, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

US (1)