Postoperative Opt-In Narcotic Treatment Study

NCT04710069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-03-04

No results posted yet for this study

Summary

pills go unused, generating waste and leaving an opportunity for misuse and abuse.

In a recent study, researchers let patients choose what medications to go home with after surgery. After their thyroid or parathyroid surgery, 96% of patients declined narcotic pain medication. They preferred to manage their pain with acetaminophen instead. Giving patients counseling and empowering them to choose significantly reduces the amount of opioids prescribed and wasted.

The aim of our study is to compare a similar "opt-in" protocol for narcotics to usual care (where patients are routinely discharged with opioids). We would elaborate upon the aforementioned study by studying patient pain scores on a more granular level once they return home.

Our study will be designed as a randomized, controlled trial. When adult patients consent for a thyroid or parathyroid surgery, they will be asked to participate in the study. Patients who are currently using narcotics would be excluded. We would then randomize participants to the "opt-in" protocol versus being provided with a standard opioid prescription after surgery. Patients in the opt-in protocol will be recommended a pain treatment regimen with over-the-counter medications, such as acetaminophen or ibuprofen. These patients will be reassured that if their pain is uncontrolled after discharge, a narcotic prescription will be called in to their pharmacy if requested.

We will assess patient pain scores and medication use in the recovery area using the electronic medical record. We will collect data on patient pain scores and medication use after discharge on a daily basis via phone call or electronically transmitted survey. We will also evaluate patients at the time of their follow-up visits. Any patient phone calls will be routed to study personnel who will fill narcotic prescription requests if requested. Finally, among patients who do receive an opioid prescription, we will track their opioid consumption.

Conditions

  • Postoperative Pain
  • Narcotic Use
  • Analgesia
  • Endocrine Surgery
  • Opioid Use
  • Opioid Abuse

Interventions

BEHAVIORAL

POINT

Patients randomized to the POINT program will be given preoperative counseling on adverse effects of opioids and expectations will be set that most patients do not require opioids for pain control after endocrine surgery, they will receive the info in writing afterwards as well. These patients will also be shown a short instructional video reiterating the counseling provided in the preoperative clinic visit. Information in the video will pertain to the expected pain after surgery, the over-the-counter options for pain control, the risks and side effects of using opioids, and reassurances that opioids may be prescribed at any time after discharge if pain is unmanageable. After the video, the patient will be provided with paperwork, requiring patient consent/signature to receive opioids if they opt into narcotic treatment. They will not be provided with a narcotic prescription if consent is not explicitly provided.

Sponsors & Collaborators

Principal Investigators

  • James Wu, MD · University of California, Los Angeles

  • Michael W Yeh, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-26
Primary Completion
2021-01-30
Completion
2021-01-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04710069 on ClinicalTrials.gov