Minimizing Narcotic Analgesics After Endocrine Surgery

• ClinicalTrials.gov Identifier: NCT03469310
• Recruitment Status: Active, not recruiting
• First Posted: March 19, 2018
• Last Update Posted: January 28, 2020
• Sponsor: Minerva Romero Arenas, MD, MPH
• Information provided by (Responsible Party): Minerva Romero Arenas, MD, MPH, Doctors Hospital at Renaissance

Tracking Information

• First Submitted Date: March 7, 2018
• First Posted Date: March 19, 2018
• Last Update Posted Date: January 28, 2020
• Actual Study Start Date: March 9, 2018
• Actual Primary Completion Date: December 21, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 12, 2018)

Staged narcotic analgesic regimen is non-inferior to narcotics in controlling pain [ Time Frame: Patient will report pain score up to two weeks after surgery ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 12, 2018)

• Is there a difference in the duration of postoperative pain requiring medication [ Time Frame: Patient will report medication requirements up to two weeks after surgery ]
  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 [ Time Frame: Patient will report medication requirements up to two weeks after surgery ]
  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 [ Time Frame: Patient will report medication requirements up to two weeks after surgery ]
  The type and quantity of pain medications used after surgery will be counted and number of patients requiring cross over will be assessed

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Minimizing Narcotic Analgesics After Endocrine Surgery
• Official Title: Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery

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.

• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: None (Open Label)
Primary Purpose: Supportive Care

Condition

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

Intervention

• Drug: Acetaminophen 500Mg Cap
  non-narcotic medication first with narcotic as second choice
  Other Name: Tylenol
• Drug: Tylenol #3 Oral Tablet
  Narcotic medication first
  Other Name: codeine-acetaminophen
• Drug: Tramadol
  non-narcotic medication first with narcotic as second choice

Study Arms

• Experimental: Acetaminophen
  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
  Interventions:

  • Drug: Acetaminophen 500Mg Cap
  • Drug: Tramadol
• Active Comparator: Codeine Acetaminophen
  Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain
  Intervention: Drug: Tylenol #3 Oral Tablet

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• Rogers SO Jr. Addressing Variability in Opioid Prescribing. JAMA Surg. 2018 Jan 1;153(1):43. doi: 10.1001/jamasurg.2017.3166.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: March 12, 2018): 126
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2020
• Actual Primary Completion Date: December 21, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Adult patients 18 years of age or older,
2. Who are undergoing thyroid or parathyroid surgery at DHR by an Endocrine Surgery faculty member,
3. Provide informed consent to participate in the study in English or Spanish,
4. Patients will be included if they are discharged the same day or on postoperative day 1,
5. Patients who undergo central lymphadenectomy will be included,
6. 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.
7. 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:

1. 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;
2. Patients allergic to any of the study drugs will be ineligible;
3. 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.
4. Patients with a formal diagnosis of hepatic failure will be ineligible
5. Patients with any diagnosis of chronic pain requiring treatment with ongoing narcotic regimen will be ineligible

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03469310
• Other Study ID Numbers: 1177315
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: De-identified information only will be made available to interested researchers.
• Supporting Materials: Study Protocol
• Supporting Materials: Informed Consent Form (ICF)

• Responsible Party: Minerva Romero Arenas, MD, MPH, Doctors Hospital at Renaissance
• Study Sponsor: Minerva Romero Arenas, MD, MPH
• Collaborators: Not Provided

Investigators

• Principal Investigator: Minerva A Romero Arenas, MD, MPH; GME General Surgery
• Principal Investigator: Samuel K Snyder, MD; GME General Surgery
• Principal Investigator: Henry A Reinhart, MD; GME General Surgery

• PRS Account: Doctors Hospital at Renaissance
• Verification Date: January 2020