Opioid Counseling Following Orthopaedic Surgery

Study Overview
=================
Brief Summary
-----------------
Postoperative pain management and opioid consumption following outpatient orthopaedic surgery may be influenced by a number of variables including knowledge of safe opioid use. A prospective randomized study is designed to understand the effect of preoperative opioid counseling on postoperative opioid consumption and the typical opioid consumption patterns following common outpatient orthopaedic surgeries. The hypothesis was that patients who received preoperative opioid counseling will consume less postoperative opioid medication and experience greater satisfaction with pain management.

Official Title
-----------------
Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling

Conditions
-----------------
Orthopedic Disorder

Intervention / Treatment
-----------------
* Other: Preoperative opioid counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing shoulder, elbow, wrist, knee, foot, and/or ankle surgery Exclusion Criteria: male of female less than 18 years old patients schedule to undergo inpatient procedures patients undergoing surgeries distal to the wrist patients undergoing surgeries under local anesthesia only

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peroperative counseling<br> | Other: Preoperative opioid counseling<br>* preoperative counseling consists of education with a brief multi-media presentation in the preoperative area on the day of surgery using a handheld tablet. The message of the preoperative counseling consisted of: 1) Background on the opioid epidemic including basic facts and consequences, 2) Description of risk factors for opioid abuse and how to consume opioids safely, 3) Information on the specific opioid the patient was prescribed and the anticipated amount and duration of use postoperatively, 4) Encouraging the use of non-opioid therapy prior to taking the prescribed opioids or quickly transitioning to non-opioid medications postoperatively, and 5) Contact information and instructions to call if the patient experienced any adverse events and/or if additional pain medication is needed.<br>|
| No Intervention: No preoperative counseling<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pills consumed | Patients asked to keep daily diary which includes number of pills consumed during the post-operative period | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine equivalents (MEQ) | MEQs is a standardized method of comparing different types of pain medication with a gold-standard. All pain medication can be converted to MEQs | Up to 6 weeks | 
| Visual Analog Scale (pain) Pain | Pain as reported by patients on a daily basis via diaries | Up to 6 weeks | 
| Patient satisfaction with pain management: 5 point Likert Scale | Satisfaction with pain management as reported daily by patients using a 5 point Likert Scale | Up to 6 weeks |