Pain Medications Following Thyroidectomy and Parathyroidectomy
Primary Purpose
Thyroid Disease, Parathyroid Diseases
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Non-narcotic group regimen
Narcotic group regimen
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Disease focused on measuring Thyroidectomy, Parathryoidectomy
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
Sites / Locations
- MetroHealth Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Narcotic group regimen
Non-narcotic group regimen
Arm Description
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.
Tylenol tablet 1000 mg by mouth every 8 hours alternating with Ibuprofen tablet 800 mg by mouth every 8 hours
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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)
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 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.
Full Information
NCT ID
NCT03640247
First Posted
July 24, 2018
Last Updated
December 23, 2019
Sponsor
MetroHealth Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03640247
Brief Title
Pain Medications Following Thyroidectomy and Parathyroidectomy
Official Title
Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Disease, Parathyroid Diseases
Keywords
Thyroidectomy, Parathryoidectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
All party or parties involved have knowledge of the interventions assigned to individual participants
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Narcotic group regimen
Arm Type
Other
Arm Description
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.
Arm Title
Non-narcotic group regimen
Arm Type
Active Comparator
Arm Description
Tylenol tablet 1000 mg by mouth every 8 hours alternating with
Ibuprofen tablet 800 mg by mouth every 8 hours
Intervention Type
Drug
Intervention Name(s)
Non-narcotic group regimen
Other Intervention Name(s)
Ibuprofen 800mg every 8 hours, Acetaminophen 500Mg Tab x2 every 8 hours
Intervention Description
Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen
Intervention Type
Drug
Intervention Name(s)
Narcotic group regimen
Other Intervention Name(s)
Ibuprofen 800mg every 8 hours, Oxycodone 5mg every 6 hours prn for pain., Hydrocodone 5 mg every 6 hours prn for pain, Tramadol 50 mg every 6 hours prn for pain, Acetaminophen 500Mg Tab x2 every 8 hours
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall mean pain as assessed by 10 point visual analogue scale from the 6 post operative day time points.
Description
10 point visual analogue scale- (0- no pain, 1-3 mild, 4-6 moderate pain, 7-10 severe pain).
Time Frame
Overall mean pain score from 6 time points (Post operative days 0,1,2,3,4,5)
Secondary Outcome Measure Information:
Title
Patient satisfaction with the pain medication regimen as assessed by 3-point likert scale from the 6 post operative day time points.
Description
3 point likert scale (1- easy to manage, 2- manageable but not easy 3- difficult to manage)
Time Frame
Mean patient satisfaction score from 6 time points (Post operative days 0,1,2,3,4,5)
Title
Total dose of oral narcotics converted into oral morphine equivalents (see below) that were taken by participants post-operatively
Description
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
Time Frame
Mean oral morphine equivalents from 6 time points (Post operative days 0,1,2,3,4,5)
Title
Mean number of office calls/contacts from the 6 post operative day time points.
Description
Mean number of office calls/contacts from participants from post operative day 0, 1,2,3,4,5.
Time Frame
Mean number of office calls/contacts from 6 time points (Post operative days 0,1,2,3,4,5)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R McHenry, MD
Organizational Affiliation
MetroHealth Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29499361
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.
Results Reference
background
PubMed Identifier
29198638
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.
Results Reference
background
PubMed Identifier
29807482
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.
Results Reference
background
PubMed Identifier
28160140
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.
Results Reference
background
PubMed Identifier
29746919
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.
Results Reference
background
PubMed Identifier
32416981
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.
Results Reference
derived
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Pain Medications Following Thyroidectomy and Parathyroidectomy
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