Minimizing Narcotic Analgesics After Endocrine Surgery

Completed · Phase 4

Conditions studied: Thyroid Cancer, Thyroid Nodule, Thyroid Neoplasms, Thyroid Goitre, Thyroid Diseases, Parathyroid Diseases, Parathyroid Adenoma, Parathyroid Hyperplasia

In brief

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.

Key facts

Study ID

NCT03469310

Run by

Minerva A Romero Arenas

People needed

126

Starts

2018-03-09

Expected to finish

2020-10-02

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• GME General Surgery Clinic — Edinburg, Texas, United States

Full record on ClinicalTrials.gov

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