Clinical trial · Interventional
Pre-operative Education Modalities to Decrease Opioid Use
Evaluation of Pre-operative Education Modalities to Decrease Opioid Use in Prostate Cancer Patients: A Prospective Randomized Control Trial
NCT04933084CI-TRIAL-00072473unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opioid-Related Disorders | — | UNRESOLVED | — |
| Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre-operative Opioid Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- During their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider.
- type
- EXPERIMENTAL
- label
- Text Handout
- description
- This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout.
- interventionNames
- Behavioral: Pre-operative Opioid Education
- type
- EXPERIMENTAL
- label
- Text handout and Pre-recorded Video
- description
- This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout AND pre-recorded video.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (12)
- BACKGROUNDOverview | Drug Overdose | CDC Injury Center. Published March 19, 2020. Accessed November 5, 2020. https://www.cdc.gov/drugoverdose/data/prescribing/overview.html
- BACKGROUNDLee 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
- BACKGROUNDBrummett 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
- BACKGROUNDKhorfan 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
- BACKGROUNDJacobs 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
- BACKGROUNDAlter 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
- 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.