Pain Medications Following Thyroidectomy and Parathyroidectomy
NCT ID: NCT03640247
Last Updated: 2019-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
126 participants
INTERVENTIONAL
2018-11-15
2019-12-01
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Narcotic group regimen
* 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.
Narcotic group regimen
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.
Non-narcotic group regimen
* Tylenol tablet 1000 mg by mouth every 8 hours alternating with
* Ibuprofen tablet 800 mg by mouth every 8 hours
Non-narcotic group regimen
Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen
Interventions
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Non-narcotic group regimen
Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen
Narcotic group regimen
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing total thyroidectomy, partial thyroidectomy or parathyroidectomy at MetroHealth Medical Center
Exclusion Criteria
* Patients who are unable or unwilling to follow study protocol requirements
18 Years
ALL
No
Sponsors
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MetroHealth Medical Center
OTHER
Responsible Party
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Christopher McHenry
MD, Director, Division of General Surgery
Principal Investigators
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Christopher R McHenry, MD
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
Locations
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MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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IRB18-00412
Identifier Type: -
Identifier Source: org_study_id