Thyroid DiseasePhase 1NCT03640247
Pain Medications Following Thyroidectomy and Parathyroidectomy
A Phase 1 study testing Non-narcotic group regimen and Narcotic group regimen in people with Thyroid Disease and Parathyroid Diseases, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of a non-narcotic, postoperative pain management regimen on patients undergoing thyroidectomy and parathyroidectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Disease, Parathyroid Diseases
- What is being tested?
- Non-narcotic group regimen and Narcotic group regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 1 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or greater
- Undergoing total thyroidectomy, partial thyroidectomy or parathyroidectomy at MetroHealth Medical Center
Who cannot join
- Patients taking narcotics prior to surgery
- Patients who are unable or unwilling to follow study protocol requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Thyroid Disease, Parathyroid Diseases
- Being tested
- Non-narcotic group regimen, Narcotic group regimen
- Keywords
- Thyroidectomy, Parathryoidectomy
- Medical subject headings
- Thyroid Diseases, Parathyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-narcotic group regimenDrug
Also called Ibuprofen 800mg every 8 hours, Acetaminophen 500Mg Tab x2 every 8 hours
Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen
Narcotic group regimenDrug
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Narcotic group regimen | Other | * 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. Receives: Drug: Narcotic group regimen |
| Non-narcotic group regimen | Active comparator | * Tylenol tablet 1000 mg by mouth every 8 hours alternating with
* Ibuprofen tablet 800 mg by mouth every 8 hours Receives: Drug: Non-narcotic group regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mean pain as assessed by 10 point visual analogue scale from the 6 post operative day time points.
10 point visual analogue scale- (0- no pain, 1-3 mild, 4-6 moderate pain, 7-10 severe pain).
Measured: Overall mean pain score from 6 time points (Post operative days 0,1,2,3,4,5)
Secondary outcomes (3)
Patient satisfaction with the pain medication regimen as assessed by 3-point likert scale from the 6 post operative day time points.
3 point likert scale (1- easy to manage, 2- manageable but not easy 3- difficult to manage)
Measured: 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
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
Measured: 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.
Mean number of office calls/contacts from participants from post operative day 0, 1,2,3,4,5.
Measured: Mean number of office calls/contacts from 6 time points (Post operative days 0,1,2,3,4,5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start15 Nov 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher McHenry, MetroHealth Medical Center
- Investigators
- Christopher R McHenry, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640247
- Sponsor's protocol ID
- IRB18-00412
- Status last verified
- Dec 2019
- First submitted
- 24 Jul 2018
- Last updated
- 26 Dec 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Fujii MH, Hodges AC, Russell RL, Roensch K, Beynnon B, Ahern TP, Holoch P, Moore JS, Ames SE, MacLean CD. Post-Discharge Opioid Prescribing and Use after Common Surgical Procedure. J Am Coll Surg. 2018 Jun;226(6):1004-1012. doi: 10.1016/j.jamcollsurg.2018.01.058. Epub 2018 Feb 28.
PubMed 29499361Hill MV, Stucke RS, Billmeier SE, Kelly JL, Barth RJ Jr. Guideline for Discharge Opioid Prescriptions after Inpatient General Surgical Procedures. J Am Coll Surg. 2018 Jun;226(6):996-1003. doi: 10.1016/j.jamcollsurg.2017.10.012. Epub 2017 Nov 30.
PubMed 29198638Long SM, Lumley CJ, Zeymo A, Davidson BJ. Prescription and Usage Pattern of Opioids after Thyroid and Parathyroid Surgery. Otolaryngol Head Neck Surg. 2019 Mar;160(3):388-393. doi: 10.1177/0194599818779776. Epub 2018 May 29.
PubMed 29807482Lou I, Chennell TB, Schaefer SC, Chen H, Sippel RS, Balentine C, Schneider DF, Moalem J. Optimizing Outpatient Pain Management After Thyroid and Parathyroid Surgery: A Two-Institution Experience. Ann Surg Oncol. 2017 Jul;24(7):1951-1957. doi: 10.1245/s10434-017-5781-y. Epub 2017 Feb 3.
PubMed 28160140Tan WH, Yu J, Feaman S, McAllister JM, Kahan LG, Quasebarth MA, Blatnik JA, Eagon JC, Awad MM, Brunt LM. Opioid Medication Use in the Surgical Patient: An Assessment of Prescribing Patterns and Use. J Am Coll Surg. 2018 Aug;227(2):203-211. doi: 10.1016/j.jamcollsurg.2018.04.032. Epub 2018 May 7.
PubMed 29746919Brady JT, Dreimiller A, Miller-Spalding S, Gesang T, Sehgal AR, McHenry CR. Are narcotic pain medications necessary after discharge following thyroidectomy and parathyroidectomy? Surgery. 2021 Jan;169(1):202-208. doi: 10.1016/j.surg.2020.03.027. Epub 2020 May 14.
PubMed 32416981
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy
- ClinicalTrials.gov ID
- NCT03640247
- Acronym / sponsor ID
- IRB18-00412
- Conditions
- Thyroid Disease, Parathyroid Diseases
- Keywords
- Thyroidectomy, Parathryoidectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use of a non-narcotic, postoperative pain management regimen on patients undergoing thyroidectomy and parathyroidectomy.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narcotic group regimen | Other | Drug: 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. |
| Non-narcotic group regimen | Active comparator | Drug: Non-narcotic group regimen* Tylenol tablet 1000 mg by mouth every 8 hours alternating with * Ibuprofen tablet 800 mg by mouth every 8 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or greater
- Undergoing total thyroidectomy, partial thyroidectomy or parathyroidectomy at MetroHealth Medical Center
Key exclusion criteria (2 listed)
- Patients taking narcotics prior to surgery
- Patients who are unable or unwilling to follow study protocol requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-narcotic group regimenAlso: Ibuprofen 800mg every 8 hours, Acetaminophen 500Mg Tab x2 every 8 hoursNon-Narcotic Group. Receives only alternating acetaminophen and ibuprofen | Drug | Non-narcotic group regimen |
| Narcotic group regimenAlso: 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 painNarcotic 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. | Drug | Narcotic group regimen |
Primary outcome
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).
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Background: PubMed 29499361Fujii MH, Hodges AC, Russell RL, Roensch K, Beynnon B, Ahern TP, Holoch P, Moore JS, Ames SE, MacLean CD. Post-Discharge Opioid Prescribing and Use after Common Surgical Procedure. J Am Coll Surg. 2018 Jun;226(6):1004-1012. doi: 10.1016/j.jamcollsurg.2018.01.058. Epub 2018 Feb 28.
- Background: PubMed 29198638Hill MV, Stucke RS, Billmeier SE, Kelly JL, Barth RJ Jr. Guideline for Discharge Opioid Prescriptions after Inpatient General Surgical Procedures. J Am Coll Surg. 2018 Jun;226(6):996-1003. doi: 10.1016/j.jamcollsurg.2017.10.012. Epub 2017 Nov 30.
- Background: PubMed 29807482Long SM, Lumley CJ, Zeymo A, Davidson BJ. Prescription and Usage Pattern of Opioids after Thyroid and Parathyroid Surgery. Otolaryngol Head Neck Surg. 2019 Mar;160(3):388-393. doi: 10.1177/0194599818779776. Epub 2018 May 29.
- Background: PubMed 28160140Lou I, Chennell TB, Schaefer SC, Chen H, Sippel RS, Balentine C, Schneider DF, Moalem J. Optimizing Outpatient Pain Management After Thyroid and Parathyroid Surgery: A Two-Institution Experience. Ann Surg Oncol. 2017 Jul;24(7):1951-1957. doi: 10.1245/s10434-017-5781-y. Epub 2017 Feb 3.
- Background: PubMed 29746919Tan WH, Yu J, Feaman S, McAllister JM, Kahan LG, Quasebarth MA, Blatnik JA, Eagon JC, Awad MM, Brunt LM. Opioid Medication Use in the Surgical Patient: An Assessment of Prescribing Patterns and Use. J Am Coll Surg. 2018 Aug;227(2):203-211. doi: 10.1016/j.jamcollsurg.2018.04.032. Epub 2018 May 7.
- Derived from this study: PubMed 32416981Brady JT, Dreimiller A, Miller-Spalding S, Gesang T, Sehgal AR, McHenry CR. Are narcotic pain medications necessary after discharge following thyroidectomy and parathyroidectomy? Surgery. 2021 Jan;169(1):202-208. doi: 10.1016/j.surg.2020.03.027. Epub 2020 May 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher R McHenry, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Non-narcotic group regimen and Narcotic group regimen in people with Thyroid Disease and Parathyroid Diseases, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640247, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.