Minimizing Narcotic Analgesics After Endocrine Surgery

NCT03469310 | Completed Phase 4 FDA Drug

• 1 other identifier: 1177315
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

endocrine surgery; opioid addiction; pain management; analgesia

Outcome Measures

Primary Outcomes (1)

• 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

  Patient will report pain score up to two weeks after surgery

Secondary Outcomes (3)

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

  Patient will report medication requirements up to two weeks after surgery

• Is there a difference in the medication requirement

  Patient will report medication requirements up to two weeks after surgery

• Staged regimen cross over to narcotic

  Patient will report medication requirements up to two weeks after surgery

Study Arms (2)

Acetaminophen

EXPERIMENTAL

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; Drug: Tramadol

Codeine Acetaminophen

ACTIVE COMPARATOR

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

Drug: Tylenol #3 Oral Tablet

Interventions

Acetaminophen 500Mg Cap DRUG

non-narcotic medication first with narcotic as second choice

Also known as: Tylenol

Acetaminophen

Tylenol #3 Oral Tablet DRUG

Narcotic medication first

Also known as: codeine-acetaminophen

Codeine Acetaminophen

Tramadol DRUG

non-narcotic medication first with narcotic as second choice

Acetaminophen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Minerva A Romero Arenas: lead

Study Sites (1)

GME General Surgery Clinic

Edinburg, Texas, 78539, United States

Location

Related Publications (6)

• 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.

  PMID: 28033313 BACKGROUND

• 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.

  PMID: 27429023 BACKGROUND

• 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.

  PMID: 27163960 BACKGROUND

• 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.

  PMID: 26987082 BACKGROUND

• 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.

  PMID: 28973092 BACKGROUND

• 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.

  PMID: 28973361 BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Nodule; Goiter; Thyroid Diseases; Parathyroid Diseases; Parathyroid Neoplasms; Opioid-Related Disorders; Agnosia

Interventions

Acetaminophen; Capsules; acetaminophen, codeine drug combination; Tramadol

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Dosage Forms; Pharmaceutical Preparations; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 19, 2018
• Study Start: March 9, 2018
• Primary Completion: December 21, 2019
• Study Completion: October 2, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)