Opioid Counseling in Pain Management

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of perioperative opioid counseling within a specific group of patient population who are undergoing bilateral reduction mammoplasty.

Detailed Description
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Prescription opioid abuse has been increasing dramatically in recent years. There is growing concern regarding the unprecedented increase in morbidity and mortality related to the use of opioids.1-2 In 2010 the rates of opioid sales, deaths, as well as associated treatment admissions have increased to more than triple the rates in 1999.1-2 Although policy makers and the media often associate the opioid crisis as a problem of nonmedical opioid abuse, evidence has suggested that opioid addiction occurs in both medical and nonmedical users.2 The Centers for Disease control and Prevention reported and warned that long-term opioid use often starts with treatment of some type of acute pain.3 Prescription opioids have been shown to be favorable in perioperative pain management, however, their effectiveness in chronic pain management is not as clear. Surgeons are among the highest opioid prescribers. Many common elective as well as trauma-related procedures have been reported as possible causes of increased prolonged opioid usage. Recent evidence also suggested that a considerable number of patients who were prescribed opioids struggle to with transitioning to non-opioid pain medications.1-6 Numerous methods have been considered and explored in effort of decreasing the misuse and abuse of prescription opioids. One of the methods being opioid counseling, in which patients are educated on the effects and risks of short-term and long-term opioid usage and physicians recommend and discuss the appropriate opioid usage as well as alternative nonopioid options. It has also been indicated that counseling is more effective if given earlier on in the patient's surgical care rather than through rushed education overview at discharge.1,4-6 Therefore, the purpose of this study is to evaluate the effect of perioperative opioid counseling within a specific group of patient population who are undergoing bilateral reduction mammoplasty.

Official Title
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A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Reduction Mammoplasty

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Other: Opioid counseling plus standard of care instructions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Elective bilateral reduction mammoplasty to be performed as outpatient Able and willing to provide informed consent Able and willing to comply with study procedures Exclusion Criteria: Age < 18 years Bilateral reduction mammoplasty planned/performed with any concomitant procedures History of preoperative opioid consumption or rehabilitation Opioid allergy Local anesthetic given during or after procedure Unable and/or unwilling to provide informed consent Unable and/or unwilling to comply with study procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients randomized to the Control Group will not receive opioid counseling and will only receive their standard of care instructions for preoperative and postoperative care. | |
| Experimental: Treatment Group<br>Patients randomized to the Treatment Group will have opioid counseling plus standard of care instructions given by the same counselor (investigator on the study) using the same counseling script at the randomization visit as well as at the visit where they come in for pre-admission testing prior to surgery (as a refresher). | Other: Opioid counseling plus standard of care instructions<br>* Same counselor (investigator on the study) will use the same counseling script at the randomization visit as well as at the visit where they come in for pre-admission testing prior to surgery (as a refresher) to counsel patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level | using standard pain scale scores recorded in daily diary - using scale 0 to 10 with 0 being no pain and 10 being worst pain imaginable | 1 month | 
| Opioid consumption | pain pill counts | 1 month | 
| Patient satisfaction | Satisfied versus not satisfied with pain management using rating categories of: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid counseling, bilateral reduction mammoplasty