Minimizing Narcotic Analgesics After Endocrine Surgery

Thyroid Cancer Clinical Trial

Official title:

Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469310
• Other study ID #: 1177315
• Status: Completed
• Phase: Phase 4
• Start date: March 9, 2018
• Est. completion date: October 2, 2020

Study information

• Verified date: May 2021
• Source: DHR Health Institute for Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2, 2020
• Est. primary completion date: December 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	GME General Surgery Clinic	Edinburg	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Minerva A Romero Arenas

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Patient will report medication requirements up to two weeks after surgery
Secondary	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	Patient will report medication requirements up to two weeks after surgery
Secondary	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	Patient will report medication requirements up to two weeks after surgery