Pain Medications Following Thyroidectomy and Parathyroidectomy

December 23, 2019 updated by: Christopher McHenry, MetroHealth Medical Center

Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy

The purpose of this study is to evaluate the use of a non-narcotic, postoperative pain management regimen on patients undergoing thyroidectomy and parathyroidectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the use of a non-narcotic, postoperative pain management regimen for patients undergoing thyroidectomy and parathyroidectomy. The investigators hypothesize that participants receiving non-narcotic pain regimens will have equivalent pain control and satisfaction to those who receive narcotic pain medicines.

The primary objective will be to identify if there is a difference in average perceived postoperative pain scores between participants who do and do not receive narcotic pain medications. Secondary outcomes will include need for breakthrough pain medications, patient satisfaction scores and the need to call the surgeon office for additional pain medications.

The participant will undergo total thyroidectomy, partial thyroidectomy or parathyroidectomy per the standard of care. The study will have no influence on the surgical procedure performed.

Following the surgery, postoperative analgesia regimens will be prescribed based on study randomization.

Narcotic group regimen (63 patients):

  • Tylenol tablet 1000 mg by mouth every 8 hours alternating with
  • Ibuprofen tablet 800 mg by mouth every 8 hours
  • Oxycodone 5 mg by mouth every 6 hours as needed for pain, #10 tablets

Non-narcotic group regimen (63 patients):

  • Tylenol tablet 1000 mg by mouth every 8 hours alternating with
  • Ibuprofen tablet 800 mg by mouth every 8 hours

Participants will be asked to complete a survey each day for the initial 5 days postoperatively. Survey data includes:

  • Average pain level using the 10-point visual analogue scale
  • Ease of following the pain regimen using a 3-point liker scale
  • Total dose of oral narcotics converted into oral morphine equivalents that were taken by participants post-operatively
  • If the patient needed to call the office due to inadequately controlled pain

If the participants do not have adequate pain control with the non-narcotic regimen, they may be prescribed additional narcotic pain medication at the discretion of the PI and remain enrolled in the study.

The investigators will also review participants charts for information regarding any postoperative office calls regarding postoperative needs (i.e. for pain medications).

The medical surgical information below is gathered as standard of care for each surgical procedure and will also be collected as part of this procedure:

  • Patient name, medical record number
  • Patient demographics (age, gender, BMI, ASA score)
  • Past medical History
  • Past surgical history
  • Past social history
  • Preoperative medications (including steroids, anticoagulation, opioid use)
  • Pre-operative diagnosis
  • Procedure performed and pain medications administered in the post-ambulatory care unit
  • Postoperative complications including need for readmission within 30 days
  • Length of stay in hospital

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 1

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
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center

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:

  • Age 18 years or greater
  • Undergoing total thyroidectomy, partial thyroidectomy or parathyroidectomy at MetroHealth Medical Center

Exclusion Criteria:

  • Patients taking narcotics prior to surgery
  • Patients who are unable or unwilling to follow study protocol requirements

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Narcotic group regimen
  • Tylenol tablet 1000 mg by mouth every 8 hours alternating with
  • Ibuprofen tablet 800 mg by mouth every 8 hours
  • Oxycodone 5 mg by mouth every 6 hours as needed for pain, #10 tablet or if needed based on patient allergies, hydrocodone 5 mg/tramadol 50 mg.
Drug: Narcotic group regimen
Narcotic Group: Alternating acetaminophen and ibuprofen, with a prescription of 10 tablets oxycodone (or if needed based on patient allergies, hydrocodone 5 mg/tramadol 50 mg) for break through pain.
Other Names:
  • Ibuprofen 800mg every 8 hours
  • Acetaminophen 500Mg Tab x2 every 8 hours
  • Oxycodone 5mg every 6 hours prn for pain.
  • Hydrocodone 5 mg every 6 hours prn for pain
  • Tramadol 50 mg every 6 hours prn for pain
ACTIVE_COMPARATOR: Non-narcotic group regimen
  • Tylenol tablet 1000 mg by mouth every 8 hours alternating with
  • Ibuprofen tablet 800 mg by mouth every 8 hours
Drug: Non-narcotic group regimen
Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen
Other Names:
  • Ibuprofen 800mg every 8 hours
  • Acetaminophen 500Mg Tab x2 every 8 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall mean pain as assessed by 10 point visual analogue scale from the 6 post operative day time points.
Time Frame: Overall mean pain score from 6 time points (Post operative days 0,1,2,3,4,5)
10 point visual analogue scale- (0- no pain, 1-3 mild, 4-6 moderate pain, 7-10 severe pain).
Overall mean pain score from 6 time points (Post operative days 0,1,2,3,4,5)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with the pain medication regimen as assessed by 3-point likert scale from the 6 post operative day time points.
Time Frame: Mean patient satisfaction score from 6 time points (Post operative days 0,1,2,3,4,5)
3 point likert scale (1- easy to manage, 2- manageable but not easy 3- difficult to manage)
Mean patient satisfaction score from 6 time points (Post operative days 0,1,2,3,4,5)
Total dose of oral narcotics converted into oral morphine equivalents (see below) that were taken by participants post-operatively
Time Frame: Mean oral morphine equivalents from 6 time points (Post operative days 0,1,2,3,4,5)

Oral morphine equivalents(OMEQ):

Hydrocodone 5mg =1 OMEQ

Oxycodone 5mg = 1.5 OMEQ

Hydromorphone 1mg = 4 OMEQ

Codeine 5mg = 0.15 OMEQ

Tramadol 5mg = 0.20 OMEQ
Mean oral morphine equivalents from 6 time points (Post operative days 0,1,2,3,4,5)
Mean number of office calls/contacts from the 6 post operative day time points.
Time Frame: Mean number of office calls/contacts from 6 time points (Post operative days 0,1,2,3,4,5)
Mean number of office calls/contacts from participants from post operative day 0, 1,2,3,4,5.
Mean number of office calls/contacts from 6 time points (Post operative days 0,1,2,3,4,5)

Collaborators and Investigators

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

Sponsor

MetroHealth Medical Center

Investigators

  • Principal Investigator: Christopher R McHenry, MD, MetroHealth Medical Center

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)

November 15, 2018

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (ACTUAL)

August 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 26, 2019

Last Update Submitted That Met QC Criteria

December 23, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB18-00412

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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