Pre-operative Education Modalities to Decrease Opioid Use

Opioid-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04933084
• Other study ID #: CRP20107
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: Benaroya Research Institute
• Contact: Eyal Kord, MD
• Phone: 206-223-6772
• Email: Eyal.Kord[@]virginiamason.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• Undergoing RARP at VMMC

• Consent to participate in the study

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Prostatectomy

Intervention

Behavioral:
• Pre-operative Opioid Education
The pre-operative education in the text handout and pre-recorded video will include the topics of: Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP. Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids. Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction.

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Benaroya Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital opioid use	Morphine equivalents used in the hospital will be calculated.	Immediately after the intervention/procedure/surgery
Primary	Post-discharge opioid use	Patient-reported number of opioid pills used after discharge (daily questionnaire).	Immediately after the intervention/procedure/surgery
Primary	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
Primary	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	Satisfaction with undergoing the surgery	Satisfaction with undergoing the surgery. (1=extremely dissatisfied, 10=extremely satisfied)	Immediately after the intervention/procedure/surgery
Secondary	Quality of life after undergoing surgery	Quality of life after the surgery. (1=worst possible QOL, 10=best possible QOL)	Immediately after the intervention/procedure/surgery
Secondary	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.	Up to 24 weeks