Clinical trial NCT03469310: Minimizing Narcotic Analgesics After Endocrine Surgery
Official title: Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: DHR Health Institute for Research and Development
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: option 1: Tylenol (also known as acetaminophen) with tramadol if needed, or option 2: Tylenol #3 as needed
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Staged narcotic analgesic regimen is non-inferior to narcotics in controlling pain
timeFrame: Patient will report pain score up to two weeks after surgery
Secondary outcomes:
measure: Is there a difference in the duration of postoperative pain requiring medication
timeFrame: Patient will report medication requirements up to two weeks after surgery
measure: Is there a difference in the medication requirement
timeFrame: Patient will report medication requirements up to two weeks after surgery
measure: Staged regimen cross over to narcotic
timeFrame: Patient will report medication requirements up to two weeks after surgery
Other outcomes:
Locations:
city: Edinburg
country: United States
facility: GME General Surgery Clinic
state: Texas
Study officials:
affiliation: GME General Surgery
name: Minerva A Romero Arenas, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: GME General Surgery
name: Samuel K Snyder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GME General Surgery
name: Henry A Reinhart, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.