Pain Medications Following Thyroidectomy and Parathyroidectomy

Thyroid Disease Clinical Trial

Official title:

Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640247
• Other study ID #: IRB18-00412
• Status: Completed
• Phase: Phase 1
• Start date: November 15, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parathyroid Diseases
• Thyroid Disease
• Thyroid Diseases

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)