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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.
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):
Non-narcotic group regimen (63 patients):
Participants will be asked to complete a survey each day for the initial 5 days postoperatively. Survey data includes:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narcotic group regimen | Other |
|
|
| Non-narcotic group regimen | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-narcotic group regimen | Drug | Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher R McHenry, MD | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29499361 | Background | Fujii MH, Hodges AC, Russell RL, Roensch K, Beynnon B, Ahern TP, Holoch P, Moore JS, Ames SE, MacLean CD. Post-Discharge Opioid Prescribing and Use after Common Surgical Procedure. J Am Coll Surg. 2018 Jun;226(6):1004-1012. doi: 10.1016/j.jamcollsurg.2018.01.058. Epub 2018 Feb 28. | |
| 29198638 | Background | Hill MV, Stucke RS, Billmeier SE, Kelly JL, Barth RJ Jr. Guideline for Discharge Opioid Prescriptions after Inpatient General Surgical Procedures. J Am Coll Surg. 2018 Jun;226(6):996-1003. doi: 10.1016/j.jamcollsurg.2017.10.012. Epub 2017 Nov 30. |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D010279 | Parathyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| D010098 | Oxycodone |
| D006853 | Hydrocodone |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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All party or parties involved have knowledge of the interventions assigned to individual participants
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| Narcotic group regimen | Drug | 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. |
|
|
| 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) |
| 29807482 | Background | Long SM, Lumley CJ, Zeymo A, Davidson BJ. Prescription and Usage Pattern of Opioids after Thyroid and Parathyroid Surgery. Otolaryngol Head Neck Surg. 2019 Mar;160(3):388-393. doi: 10.1177/0194599818779776. Epub 2018 May 29. |
| 28160140 | Background | Lou I, Chennell TB, Schaefer SC, Chen H, Sippel RS, Balentine C, Schneider DF, Moalem J. Optimizing Outpatient Pain Management After Thyroid and Parathyroid Surgery: A Two-Institution Experience. Ann Surg Oncol. 2017 Jul;24(7):1951-1957. doi: 10.1245/s10434-017-5781-y. Epub 2017 Feb 3. |
| 29746919 | Background | Tan WH, Yu J, Feaman S, McAllister JM, Kahan LG, Quasebarth MA, Blatnik JA, Eagon JC, Awad MM, Brunt LM. Opioid Medication Use in the Surgical Patient: An Assessment of Prescribing Patterns and Use. J Am Coll Surg. 2018 Aug;227(2):203-211. doi: 10.1016/j.jamcollsurg.2018.04.032. Epub 2018 May 7. |
| 32416981 | Derived | Brady JT, Dreimiller A, Miller-Spalding S, Gesang T, Sehgal AR, McHenry CR. Are narcotic pain medications necessary after discharge following thyroidectomy and parathyroidectomy? Surgery. 2021 Jan;169(1):202-208. doi: 10.1016/j.surg.2020.03.027. Epub 2020 May 14. |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D008055 | Lipids |