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Completed

NCT Number: NCT03640247

Pain Medications 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-narcotic group regimen

Drug

Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen

Other names: Ibuprofen 800mg every 8 hours, Acetaminophen 500Mg Tab x2 every 8 hours

Narcotic group regimen

Drug

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, 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, Acetaminophen 500Mg Tab x2 every 8 hours

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Official study title

Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Dec 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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