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Minimizing Narcotic Analgesics After Endocrine Surgery

Primary Purpose

Thyroid Cancer, Thyroid Nodule, Thyroid Neoplasms

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Acetaminophen 500Mg Cap

Tylenol #3 Oral Tablet

Tramadol

About this trial

This is an interventional supportive care trial for Thyroid Cancer focused on measuring endocrine surgery, opioid addiction, pain management, analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients 18 years of age or older,
Who are undergoing thyroid or parathyroid surgery at DHR by an Endocrine Surgery faculty member,
Provide informed consent to participate in the study in English or Spanish,
Patients will be included if they are discharged the same day or on postoperative day 1,
Patients who undergo central lymphadenectomy will be included,
Patients who undergo two operations within a 2-week period (for example a thyroid lobectomy followed by subsequent completion thyroidectomy) will only have the postoperative narcotic requirements following the initial operation included for the study analysis.
Patients who have a complication, such as seroma or hematoma, requiring return to the operating room within 48 hours will be included in the study for the initial operation only.

Exclusion Criteria:

Patients who undergo lateral neck lymph node dissection will be excluded from the study due to the extent of the operation requiring a different analgesic regimen;
Patients allergic to any of the study drugs will be ineligible;
Patients who undergo two operations within a 2-week period (for example a thyroid lobectomy followed by subsequent completion thyroidectomy) will only have the initial operation included for the study analysis.
Patients with a formal diagnosis of hepatic failure will be ineligible
Patients with any diagnosis of chronic pain requiring treatment with ongoing narcotic regimen will be ineligible

Sites / Locations

GME General Surgery Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acetaminophen

Codeine Acetaminophen

Arm Description

Tylenol (also known as acetaminophen) 1000mg every 6 hours for 3 days and tramadol 50 mg every 6 hours as needed for moderate to severe pain

Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain

Outcomes

Primary Outcome Measures

Staged narcotic analgesic regimen is non-inferior to narcotics in controlling pain

Patient pain scores will be logged using Wong-Baker FACES pain rating scale (range 0-10) and scores will be assessed for differences between the study arms

Secondary Outcome Measures

Is there a difference in the duration of postoperative pain requiring medication

The number of days after surgery that participants required pain medications will be counted and assessed for difference between the study arms

Is there a difference in the medication requirement

The type and quantity of pain medications used after surgery will be counted and assessed for difference between the study arms

Staged regimen cross over to narcotic

The type and quantity of pain medications used after surgery will be counted and number of patients requiring cross over will be assessed

Full Information

NCT ID

NCT03469310

First Posted

March 7, 2018

Last Updated

May 7, 2021

Sponsor

Minerva A Romero Arenas

1. Study Identification

Unique Protocol Identification Number

NCT03469310

Brief Title

Minimizing Narcotic Analgesics After Endocrine Surgery

Official Title

Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

March 9, 2018 (Actual)

Primary Completion Date

December 21, 2019 (Actual)

Study Completion Date

October 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Minerva A Romero Arenas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This research is being done to better understand and test if the investigators can minimize narcotic medication for controlling pain after thyroid or parathyroid surgery. This research will be performed at Doctors Hospital At Renaissance in the investigators clinic and the perioperative area. Participants will be randomly chosen to receive one of two options for pain management that the investigators are already using in the care of patients after surgery. One option includes a narcotic medication and one option includes a non-narcotic and a narcotic as needed. Participants will be asked to complete a form about the level of pain and how much pain medication was needed after surgery in the hospital and while at home. Participants will not have to do any additional visits to participate in this study. The investigators will obtain the research materials at the same time as the usual care visits around the participants' surgery.

Detailed Description

A study team member will give the participant a copy of the informed consent form to read. Participants will have a chance to ask questions about the study before agreeing to participate. If participants agree, they will be randomly chosen to receive one of two options for pain management that the investigators are already using in the care of patients (option 1: Tylenol (also known as acetaminophen) with tramadol if needed, or option 2: Tylenol #3 as needed) after surgery. Participants will be asked to complete a form about the level of pain and how much pain medication was needed after surgery in the hospital and while at home. Participants will come to the GME General Surgery Center approximately one week after surgery for a post-operative visit so that the investigators can see how much pain medication was used and how much pain the participant had in the first few days after surgery. Participants will not have to do any additional visits to participate in this study. The investigators will obtain the research materials at the same time as the usual care visits around the participants' surgery. It should take approximately 2 minutes each day to complete.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Cancer, Thyroid Nodule, Thyroid Neoplasms, Thyroid Goitre, Thyroid Diseases, Parathyroid Diseases, Parathyroid Adenoma, Parathyroid Hyperplasia

Keywords

endocrine surgery, opioid addiction, pain management, analgesia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

option 1: Tylenol (also known as acetaminophen) with tramadol if needed, or option 2: Tylenol #3 as needed

Masking

None (Open Label)

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acetaminophen

Arm Type

Experimental

Arm Description

Tylenol (also known as acetaminophen) 1000mg every 6 hours for 3 days and tramadol 50 mg every 6 hours as needed for moderate to severe pain

Arm Title

Codeine Acetaminophen

Arm Type

Active Comparator

Arm Description

Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain

Intervention Type

Drug

Intervention Name(s)

Acetaminophen 500Mg Cap

Other Intervention Name(s)

Tylenol

Intervention Description

non-narcotic medication first with narcotic as second choice

Intervention Type

Drug

Intervention Name(s)

Tylenol #3 Oral Tablet

Other Intervention Name(s)

codeine-acetaminophen

Intervention Description

Narcotic medication first

Intervention Type

Drug

Intervention Name(s)

Tramadol

Intervention Description

non-narcotic medication first with narcotic as second choice

Primary Outcome Measure Information:

Title

Staged narcotic analgesic regimen is non-inferior to narcotics in controlling pain

Description

Patient pain scores will be logged using Wong-Baker FACES pain rating scale (range 0-10) and scores will be assessed for differences between the study arms

Time Frame

Patient will report pain score up to two weeks after surgery

Secondary Outcome Measure Information:

Title

Is there a difference in the duration of postoperative pain requiring medication

Description

The number of days after surgery that participants required pain medications will be counted and assessed for difference between the study arms

Time Frame

Patient will report medication requirements up to two weeks after surgery

Title

Is there a difference in the medication requirement

Description

The type and quantity of pain medications used after surgery will be counted and assessed for difference between the study arms

Time Frame

Patient will report medication requirements up to two weeks after surgery

Title

Staged regimen cross over to narcotic

Description

The type and quantity of pain medications used after surgery will be counted and number of patients requiring cross over will be assessed

Time Frame

Patient will report medication requirements up to two weeks after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients 18 years of age or older, Who are undergoing thyroid or parathyroid surgery at DHR by an Endocrine Surgery faculty member, Provide informed consent to participate in the study in English or Spanish, Patients will be included if they are discharged the same day or on postoperative day 1, Patients who undergo central lymphadenectomy will be included, Patients who undergo two operations within a 2-week period (for example a thyroid lobectomy followed by subsequent completion thyroidectomy) will only have the postoperative narcotic requirements following the initial operation included for the study analysis. Patients who have a complication, such as seroma or hematoma, requiring return to the operating room within 48 hours will be included in the study for the initial operation only. Exclusion Criteria: Patients who undergo lateral neck lymph node dissection will be excluded from the study due to the extent of the operation requiring a different analgesic regimen; Patients allergic to any of the study drugs will be ineligible; Patients who undergo two operations within a 2-week period (for example a thyroid lobectomy followed by subsequent completion thyroidectomy) will only have the initial operation included for the study analysis. Patients with a formal diagnosis of hepatic failure will be ineligible Patients with any diagnosis of chronic pain requiring treatment with ongoing narcotic regimen will be ineligible

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minerva A Romero Arenas, MD, MPH

Organizational Affiliation

GME General Surgery

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Samuel K Snyder, MD

Organizational Affiliation

GME General Surgery

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Henry A Reinhart, MD

Organizational Affiliation

GME General Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

GME General Surgery Clinic

City

Edinburg

State/Province

Texas

ZIP/Postal Code

78539

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified information only will be made available to interested researchers.

Citations:

PubMed Identifier

28033313

Citation

Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.

Results Reference

background

PubMed Identifier

27429023

Citation

Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.

Results Reference

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PubMed Identifier

27163960

Citation

Jiang X, Orton M, Feng R, Hossain E, Malhotra NR, Zager EL, Liu R. Chronic Opioid Usage in Surgical Patients in a Large Academic Center. Ann Surg. 2017 Apr;265(4):722-727. doi: 10.1097/SLA.0000000000001780.

Results Reference

background

PubMed Identifier

26987082

Citation

Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1. Erratum In: MMWR Recomm Rep. 2016;65(11):295.

Results Reference

background

PubMed Identifier

28973092

Citation

Scully RE, Schoenfeld AJ, Jiang W, Lipsitz S, Chaudhary MA, Learn PA, Koehlmoos T, Haider AH, Nguyen LL. Defining Optimal Length of Opioid Pain Medication Prescription After Common Surgical Procedures. JAMA Surg. 2018 Jan 1;153(1):37-43. doi: 10.1001/jamasurg.2017.3132.

Results Reference

background

PubMed Identifier

28973361

Citation

Rogers SO Jr. Addressing Variability in Opioid Prescribing. JAMA Surg. 2018 Jan 1;153(1):43. doi: 10.1001/jamasurg.2017.3166. No abstract available.

Results Reference

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Minimizing Narcotic Analgesics After Endocrine Surgery

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