Pain Medications Following Thyroidectomy and Parathyroidectomy

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ClinicalTrials.gov Identifier: NCT03640247

Recruitment Status : Completed

First Posted : August 21, 2018

Last Update Posted : December 26, 2019

Sponsor:

Information provided by (Responsible Party):

Christopher McHenry, MetroHealth Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Thyroid Disease Parathyroid Diseases	Drug: Non-narcotic group regimen Drug: Narcotic group regimen	Phase 1

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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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	126 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Masking Description:	All party or parties involved have knowledge of the interventions assigned to individual participants
Primary Purpose:	Treatment
Official Title:	Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy
Actual Study Start Date :	November 15, 2018
Actual Primary Completion Date :	December 1, 2019
Actual Study Completion Date :	December 1, 2019

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: 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 Names: 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
Active Comparator: Non-narcotic group regimen Tylenol tablet 1000 mg by mouth every 8 hours alternating with Ibuprofen tablet 800 mg by mouth every 8 hours	Drug: Non-narcotic group regimen Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen Other Names: Ibuprofen 800mg every 8 hours Acetaminophen 500Mg Tab x2 every 8 hours

Arm

Intervention/treatment

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.

Drug: 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 Names:

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

Active Comparator: Non-narcotic group regimen

Tylenol tablet 1000 mg by mouth every 8 hours alternating with
Ibuprofen tablet 800 mg by mouth every 8 hours

Drug: Non-narcotic group regimen

Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen

Other Names:

Ibuprofen 800mg every 8 hours
Acetaminophen 500Mg Tab x2 every 8 hours

Outcome Measures

Primary Outcome Measures :

Overall mean pain as assessed by 10 point visual analogue scale from the 6 post operative day time points. [ Time Frame: Overall mean pain score from 6 time points (Post operative days 0,1,2,3,4,5) ]
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. [ Time Frame: Mean patient satisfaction score from 6 time points (Post operative days 0,1,2,3,4,5) ]
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 [ Time Frame: Mean oral morphine equivalents from 6 time points (Post operative days 0,1,2,3,4,5) ]
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. [ Time Frame: Mean number of office calls/contacts from 6 time points (Post operative days 0,1,2,3,4,5) ]
Mean number of office calls/contacts from participants from post operative day 0, 1,2,3,4,5.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640247

Locations

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United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109

Sponsors and Collaborators

MetroHealth Medical Center

Investigators

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Principal Investigator:	Christopher R McHenry, MD	MetroHealth Medical Center

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Christopher McHenry, MD, Director, Division of General Surgery, MetroHealth Medical Center
ClinicalTrials.gov Identifier:	NCT03640247
Other Study ID Numbers:	IRB18-00412
First Posted:	August 21, 2018 Key Record Dates
Last Update Posted:	December 26, 2019
Last Verified:	December 2019

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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

Keywords provided by Christopher McHenry, MetroHealth Medical Center:


Thyroidectomy Parathryoidectomy

Additional relevant MeSH terms:

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Thyroid Diseases Parathyroid Diseases Endocrine System Diseases Acetaminophen Ibuprofen Oxycodone Tramadol Hydrocodone Narcotics Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Central Nervous System Depressants Antitussive Agents Respiratory System Agents

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