Pain Medications Following Thyroidectomy and Parathyroidectomy

Sponsor

MetroHealth Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03640247

Collaborator

(none)

126

Enrollment

Location

Arms

12.5

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Disease Parathyroid Diseases	Drug: Non-narcotic group regimen Drug: Narcotic group regimen	Phase 1

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

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

All party or parties involved have knowledge of the interventions assigned to individual participants

Primary Purpose:

Treatment

Official Title:

Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy

Actual Study Start Date :

Nov 15, 2018

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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 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
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

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

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

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

Outcome Measures

Primary Outcome Measures

Overall mean pain as assessed by 10 point visual analogue scale from the 6 post operative day time points. [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 Outcome Measures

Patient satisfaction with the pain medication regimen as assessed by 3-point likert scale from the 6 post operative day time points. [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)
Total dose of oral narcotics converted into oral morphine equivalents (see below) that were taken by participants post-operatively [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 number of office calls/contacts from the 6 post operative day time points. [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.