Minimizing Narcotic Analgesics After Endocrine Surgery

Phase 4

Completed

• Conditions: Thyroid Diseases; Parathyroid Hyperplasia; Thyroid Cancer; Thyroid Goitre; Thyroid Nodule; Thyroid Neoplasms; Parathyroid Adenoma; Parathyroid Diseases
• Interventions: Drug: Tylenol #3 Oral Tablet; Drug: Acetaminophen 500Mg Cap; Drug: Tramadol

• Registration Number: NCT03469310
• Lead Sponsor: Minerva A Romero Arenas

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.

Study Timeline

• Study First Submitted: 2018-03-07
• Study Start: 2018-03-09
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Primary Completion: 2019-12-21
• Study Completion: 2020-10-02
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Codeine Acetaminophen	Tylenol #3 Oral Tablet	Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain
Acetaminophen	Acetaminophen 500Mg Cap	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
Acetaminophen	Tramadol	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

Primary Outcome Measures

Name	Time	Method
Staged narcotic analgesic regimen is non-inferior to narcotics in controlling pain	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

Name	Time	Method
Is there a difference in the duration of postoperative pain requiring medication	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
Is there a difference in the medication requirement	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
Staged regimen cross over to narcotic	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

Trial Locations

Locations (1)

GME General Surgery Clinic; 🇺🇸 Edinburg, Texas, United States