Pain Management After Surgery

Study Overview
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Brief Summary
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Following outpatient orthopaedic surgery, adequate pain control is imperative both for patient satisfaction and for improved recovery and rehabilitation. Opioids are frequently utilized for postoperative pain control, however they can be addictive and are known to have many deleterious effects. Recent studies have demonstrated the effectiveness of a wide variety of multi-modal postoperative pain regimens in providing adequate pain control while also decreasing opioid usage. However, the most effective multi-modal pain regimen for postoperative pain control remains unclear. This prospective, randomized study intends to investigate the efficacy of a multi-modal postoperative pain regimen compared to a traditional opioid-only pain regimen following elective outpatient orthopaedic surgery of the hand, wrist, foot, or ankle.

Official Title
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Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: OxyCODONE 5 mg Oral Tablet
* Drug: Acetaminophen 500Mg Tab
* Drug: Naproxen 500 Mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old undergoing elective outpatient orthopaedic surgery under general anesthesia. Exclusion Criteria: Age < 18 years old Non-English speaking allergy to or medical contraindication to taking oxycodone (or other opioids), acetaminophen, or Naprosyn (or other NSAIDs). currently taking opioid medications history of chronic opioid therapy for chronic pain surgery being performed under local anesthesia only, without general anesthesia or sedation

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxycodone Group (Control Group)<br>Patients will receive oxycodone as needed after surgery | Drug: OxyCODONE 5 mg Oral Tablet<br>* Oxycodone will be given every 4 hours as needed for 2 weeks after surgery<br>|
| Active Comparator: Oxycodone+ Naproxen/Acetaminophen (Study Group)<br>each patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery | Drug: OxyCODONE 5 mg Oral Tablet<br>* Oxycodone will be given every 4 hours as needed for 2 weeks after surgery<br>Drug: Acetaminophen 500Mg Tab<br>* Acetaminophen will be taken every 4 hours for 2 weeks after surgery<br>Drug: Naproxen 500 Mg<br>* Naproxen will be taken every 12 hours for 2 weeks after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | With the use of an 11 point numeric rating scale (NRS) daily satisfaction with their pain regimen, patients pain level and medication usage will be recorded. | 14 days |