Clinical trial NCT03640247: Pain Medications Following Thyroidectomy and Parathyroidectomy
Official title: Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thyroid Disease
Parathyroid Diseases
Keywords: Thyroidectomy
Parathryoidectomy
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Overall mean pain as assessed by 10 point visual analogue scale from the 6 post operative day time points.
timeFrame: Overall mean pain score from 6 time points (Post operative days 0,1,2,3,4,5)
Secondary outcomes:
measure: Patient satisfaction with the pain medication regimen as assessed by 3-point likert scale from the 6 post operative day time points.
timeFrame: Mean patient satisfaction score from 6 time points (Post operative days 0,1,2,3,4,5)
measure: Total dose of oral narcotics converted into oral morphine equivalents (see below) that were taken by participants post-operatively
timeFrame: Mean oral morphine equivalents from 6 time points (Post operative days 0,1,2,3,4,5)
measure: Mean number of office calls/contacts from the 6 post operative day time points.
timeFrame: Mean number of office calls/contacts from 6 time points (Post operative days 0,1,2,3,4,5)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Christopher R McHenry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.