Minimizing Narcotic Analgesics After Endocrine Surgery

Sponsor

Minerva A Romero Arenas (Other)

Overall Status

Completed

CT.gov ID

NCT03469310

Collaborator

(none)

126

Enrollment

Location

Arms

30.8

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Cancer Thyroid Nodule Thyroid Neoplasms Thyroid Goitre Thyroid Diseases Parathyroid Diseases Parathyroid Adenoma Parathyroid Hyperplasia	Drug: Acetaminophen 500Mg Cap Drug: Tylenol #3 Oral Tablet Drug: Tramadol	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery

Actual Study Start Date :

Mar 9, 2018

Actual Primary Completion Date :

Dec 21, 2019

Actual Study Completion Date :

Oct 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acetaminophen 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 non-narcotic medication first with narcotic as second choice Other Names: Tylenol Drug: Tramadol non-narcotic medication first with narcotic as second choice
Active Comparator: Codeine Acetaminophen Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain	Drug: Tylenol #3 Oral Tablet Narcotic medication first Other Names: codeine-acetaminophen

Arm

Intervention/Treatment

Experimental: Acetaminophen

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

non-narcotic medication first with narcotic as second choice

Other Names:

Tylenol

Drug: Tramadol

non-narcotic medication first with narcotic as second choice

Active Comparator: Codeine Acetaminophen

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

Drug: Tylenol #3 Oral Tablet

Narcotic medication first

Other Names:

codeine-acetaminophen

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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