Post Operative Analgesia and Patient Satisfaction

Study Overview
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Brief Summary
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To understand how patients perceive the quality of care they receive when given different post-operative analgesic medications. Specifically the investigators want to assess whether patients who receive non-opioid analgesia following surgery endorse appropriate quality and satisfaction with their care compared to those who receive opioid medication.

Detailed Description
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It is routine practice to give analgesic medication after any surgical procedure to provide adequate pain control for patients. However with the increase in abuse of opioid prescription medications, physicians have given a new emphasis to different pain regimens that aim to limit the use of opioid medications. The investigator's previous clinical trial demonstrated that for patients undergoing outpatient otolaryngology procedures, not only does Ibuprofen provide equally effective analgesia compared to opioid medication but it can also decrease overall opioid requirement. In the current proposed study, the investigators wish to build on previous work. The investigators hypothesize that with the addition of Acetaminophen to Ibuprofen, patients undergoing outpatient otolaryngology procedures may not require opioid analgesia at all. While numerous studies corroborate these results, there is little information about patients' satisfaction with their care in light of a shifting emphasis on decreasing opioid prescription. The primary goal of the current study is to better understand patients' perception of care and level of satisfaction when given opioid versus non-opioid postoperative analgesia. If there is conflicting data with regards to patients reporting adequate pain control but poor satisfaction, then perhaps further public health intervention may be necessary to provide additional patient education to help re-establish appropriate and safe patient expectations for postsurgical analgesia.

Official Title
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Assessing Perceived Quality of Care With Differing Pain Management Protocols After Outpatient Otolaryngology Procedures

Conditions
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Postoperative Pain, Patient Satisfaction, Analgesia

Intervention / Treatment
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* Drug: Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET
* Drug: Ibuprofen 600 mg
* Drug: Acetaminophen 650 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages of 18 and 89 years of age Patients undergoing the following outpatient procedures at a LLUHS associated surgical facility: total or partial thyroidectomy parathyroidectomy parotidectomy submandibular gland excision neck mass excision facial mass excision MOHS defect repair excision of cutaneous lesions Other surgeries may qualify and will be assessed on a case by case basis. Exclusion Criteria: Patients under 18 years old or older than 89 years old Those allergic to Hydrocodone, Acetaminophen, or NSAIDS Patients who are pregnant Patients with chronic medical conditions including hepatic/renal disease that precludes their ability to utilize the study medications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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
Interventional Model Description: Patients will be randomized to one of three groups prior to surgery. Patients will be prescribed Hydrocodone/acetaminophen, Ibuprofen, and/or Acetaminophen. Patients assigned to treatment Group 1 will take the opioid medication for initial pain control followed by Ibuprofen if pain is not adequately controlled. Group 2 patients will take Ibuprofen for initial pain control followed by the opioid medication if pain is not adequately controlled. Group 3 patients will take Ibuprofen for initial pain control followed by Acetaminophen if pain is not adequately controlled.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Hydrocodone/Acetaminophen and Ibuprofen<br>This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. | Drug: Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET<br>* Patients are instructed to take Hydrocodone/acetaminophen 5 mg-325 mg oral tablets every 6 hours as needed for treatment of severe pain<br>* Other names: Norco;Drug: Ibuprofen 600 mg<br>* Patients will take ibuprofen 600 mg every 6 hours as needed<br>* Other names: Advil, Motrin, NSAID;|
| Experimental: Group 2: Ibuprofen and Hydrocodone/acetaminophen<br>This group will take Ibuprofen 600mg every 6 hours as needed for pain control If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. | Drug: Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET<br>* Patients are instructed to take Hydrocodone/acetaminophen 5 mg-325 mg oral tablets every 6 hours as needed for treatment of severe pain<br>* Other names: Norco;Drug: Ibuprofen 600 mg<br>* Patients will take ibuprofen 600 mg every 6 hours as needed<br>* Other names: Advil, Motrin, NSAID;|
| Experimental: Group 3: Ibuprofen and Acetaminophen<br>This group will take Ibuprofen 600mg every 6 hours as needed for pain control If pain is not controlled after 60 minutes then can take Acetaminophen 650mg every 6 hours as needed for additional pain control. | Drug: Ibuprofen 600 mg<br>* Patients will take ibuprofen 600 mg every 6 hours as needed<br>* Other names: Advil, Motrin, NSAID;Drug: Acetaminophen 650 MG<br>* Patients will take Tylenol 650mg every 6 hours as needed<br>* Other names: Tylenol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with post operative pain control | Patients will be surveyed if they were satisfied with their pain regimen and efficacy of pain control on a scale of 1-5. With 1 being very unsatisfied and 5 being very satisfied. | First clinic visit after surgery (7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of analgesic regimen and patient attitudes toward treatment they received | Patients attitude and overall experience with regards to their pain management will be assessed via the following questions: How many total days do you estimate that you required medication for your pain? If you were in a group that received hydrocodone, how many pills do you estimate that you took? If you were to have another surgery, would you ask your surgeon for a similar pain regimen? Was this surgery more painful than you anticipated? | First clinic visit after surgery (7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Otolaryngology, Head and Neck surgery, Outpatient surgery, Same day surgery, Post operative pain, Patient satisfaction, Post operative analgesia, NSAID, Acetaminophen, Hydrocodone