Minimizing Narcotic Analgesics After Endocrine Surgery

May 7, 2021 updated by: Minerva A Romero Arenas

Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Edinburg, Texas, United States, 78539
        • GME General Surgery Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staged narcotic analgesic regimen is non-inferior to narcotics in controlling pain
Time Frame: 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
Patient will report pain score up to two weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is there a difference in the duration of postoperative pain requiring medication
Time Frame: 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
Patient will report medication requirements up to two weeks after surgery
Is there a difference in the medication requirement
Time Frame: 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
Patient will report medication requirements up to two weeks after surgery
Staged regimen cross over to narcotic
Time Frame: 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
Patient will report medication requirements up to two weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minerva A Romero Arenas

Investigators

  • Principal Investigator: Minerva A Romero Arenas, MD, MPH, GME General Surgery
  • Principal Investigator: Samuel K Snyder, MD, GME General Surgery
  • Principal Investigator: Henry A Reinhart, MD, GME General Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2018

Primary Completion (Actual)

December 21, 2019

Study Completion (Actual)

October 2, 2020

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1177315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified information only will be made available to interested researchers.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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