Pain Medications Following Thyroidectomy and Parathyroidectomy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of a non-narcotic, postoperative pain management regimen on patients undergoing thyroidectomy and parathyroidectomy.

Detailed Description
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The purpose of this study is to evaluate the use of a non-narcotic, postoperative pain management regimen for patients undergoing thyroidectomy and parathyroidectomy. The investigators hypothesize that participants receiving non-narcotic pain regimens will have equivalent pain control and satisfaction to those who receive narcotic pain medicines. The primary objective will be to identify if there is a difference in average perceived postoperative pain scores between participants who do and do not receive narcotic pain medications. Secondary outcomes will include need for breakthrough pain medications, patient satisfaction scores and the need to call the surgeon office for additional pain medications. The participant will undergo total thyroidectomy, partial thyroidectomy or parathyroidectomy per the standard of care. The study will have no influence on the surgical procedure performed. Following the surgery, postoperative analgesia regimens will be prescribed based on study randomization. Narcotic group regimen (63 patients): Tylenol tablet 1000 mg by mouth every 8 hours alternating with Ibuprofen tablet 800 mg by mouth every 8 hours Oxycodone 5 mg by mouth every 6 hours as needed for pain, #10 tablets Non-narcotic group regimen (63 patients): Tylenol tablet 1000 mg by mouth every 8 hours alternating with Ibuprofen tablet 800 mg by mouth every 8 hours Participants will be asked to complete a survey each day for the initial 5 days postoperatively. Survey data includes: Average pain level using the 10-point visual analogue scale Ease of following the pain regimen using a 3-point liker scale Total dose of oral narcotics converted into oral morphine equivalents that were taken by participants post-operatively If the patient needed to call the office due to inadequately controlled pain If the participants do not have adequate pain control with the non-narcotic regimen, they may be prescribed additional narcotic pain medication at the discretion of the PI and remain enrolled in the study. The investigators will also review participants charts for information regarding any postoperative office calls regarding postoperative needs (i.e. for pain medications). The medical surgical information below is gathered as standard of care for each surgical procedure and will also be collected as part of this procedure: Patient name, medical record number Patient demographics (age, gender, BMI, ASA score) Past medical History Past surgical history Past social history Preoperative medications (including steroids, anticoagulation, opioid use) Pre-operative diagnosis Procedure performed and pain medications administered in the post-ambulatory care unit Postoperative complications including need for readmission within 30 days Length of stay in hospital

Official Title
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Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy

Conditions
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Thyroid Disease, Parathyroid Diseases

Intervention / Treatment
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* Drug: Non-narcotic group regimen
* Drug: Narcotic group regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or greater Undergoing total thyroidectomy, partial thyroidectomy or parathyroidectomy at MetroHealth Medical Center Exclusion Criteria: Patients taking narcotics prior to surgery Patients who are unable or unwilling to follow study protocol requirements

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Narcotic group regimen<br>Tylenol tablet 1000 mg by mouth every 8 hours alternating with Ibuprofen tablet 800 mg by mouth every 8 hours Oxycodone 5 mg by mouth every 6 hours as needed for pain, #10 tablet or if needed based on patient allergies, hydrocodone 5 mg/tramadol 50 mg. | Drug: Narcotic group regimen<br>* Narcotic Group: Alternating acetaminophen and ibuprofen, with a prescription of 10 tablets oxycodone (or if needed based on patient allergies, hydrocodone 5 mg/tramadol 50 mg) for break through pain.<br>* Other names: Acetaminophen 500Mg Tab x2 every 8 hours;|
| Active Comparator: Non-narcotic group regimen<br>Tylenol tablet 1000 mg by mouth every 8 hours alternating with Ibuprofen tablet 800 mg by mouth every 8 hours | Drug: Non-narcotic group regimen<br>* Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen<br>* Other names: Acetaminophen 500Mg Tab x2 every 8 hours;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mean pain as assessed by 10 point visual analogue scale from the 6 post operative day time points. | 10 point visual analogue scale- (0- no pain, 1-3 mild, 4-6 moderate pain, 7-10 severe pain). | Overall mean pain score from 6 time points (Post operative days 0,1,2,3,4,5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with the pain medication regimen as assessed by 3-point likert scale from the 6 post operative day time points. | 3 point likert scale (1- easy to manage, 2- manageable but not easy 3- difficult to manage) | Mean patient satisfaction score from 6 time points (Post operative days 0,1,2,3,4,5) | 
| Total dose of oral narcotics converted into oral morphine equivalents (see below) that were taken by participants post-operatively | Oral morphine equivalents(OMEQ): Hydrocodone 5mg =1 OMEQ Oxycodone 5mg = 1.5 OMEQ Hydromorphone 1mg = 4 OMEQ Codeine 5mg = 0.15 OMEQ Tramadol 5mg = 0.20 OMEQ | Mean oral morphine equivalents from 6 time points (Post operative days 0,1,2,3,4,5) | 
| Mean number of office calls/contacts from the 6 post operative day time points. | Mean number of office calls/contacts from participants from post operative day 0, 1,2,3,4,5. | Mean number of office calls/contacts from 6 time points (Post operative days 0,1,2,3,4,5) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroidectomy, Parathryoidectomy