Minimizing Narcotic Analgesics After Endocrine Surgery

• ClinicalTrials.gov Identifier: NCT03469310
• Recruitment Status: Completed
• First Posted: March 19, 2018
• Last Update Posted: May 11, 2021
• Sponsor: Minerva A Romero Arenas
• Information provided by (Responsible Party): Minerva A Romero Arenas, DHR Health Institute for Research and Development

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.

Condition or disease	Intervention/treatment	Phase
Thyroid Cancer; Thyroid Nodule; Thyroid Neoplasms; Thyroid Goitre; Thyroid Diseases; Parathyroid Diseases; Parathyroid Adenoma; Parathyroid Hyperplasia	Drug: Acetaminophen 500Mg Cap; Drug: Tylenol #3 Oral Tablet; Drug: Tramadol	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 126 participants
• 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
• Official Title: Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery
• Actual Study Start Date: March 9, 2018
• Actual Primary Completion Date: December 21, 2019
• Actual Study Completion Date: October 2, 2020

Arms and Interventions

Arm	Intervention/treatment
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	Drug: Acetaminophen 500Mg Cap; non-narcotic medication first with narcotic as second choice; Other Name: Tylenol; Drug: Tramadol; non-narcotic medication first with narcotic as second choice
Active Comparator: Codeine Acetaminophen; Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain	Drug: Tylenol #3 Oral Tablet; Narcotic medication first; Other Name: codeine-acetaminophen

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Texas

GME General Surgery Clinic

Edinburg, Texas, United States, 78539

Sponsors and Collaborators

Minerva A Romero Arenas

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

More Information

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. No abstract available.

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. No abstract available.

• Responsible Party: Minerva A Romero Arenas, Principal Investigator, DHR Health Institute for Research and Development
• ClinicalTrials.gov Identifier: NCT03469310
• Other Study ID Numbers: 1177315
• First Posted: March 19, 2018
• Last Update Posted: May 11, 2021
• Last Verified: May 2021

Individual Participant Data (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; Informed Consent Form (ICF)

• 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 Minerva A Romero Arenas, DHR Health Institute for Research and Development:

endocrine surgery; opioid addiction; pain management; analgesia

Additional relevant MeSH terms:

Thyroid Neoplasms; Adenoma; Thyroid Nodule; Parathyroid Neoplasms; Thyroid Diseases; Goiter; Parathyroid Diseases; Hyperplasia; Endocrine System Diseases; Pathologic Processes; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Acetaminophen; Tramadol; Codeine; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Antitussive Agents; Respiratory System Agents