Pain Medications Following Thyroidectomy and Parathyroidectomy

MetroHealth Medical Center

Status and phase: Completed; Phase 1

Conditions: Thyroid Disease; Parathyroid Diseases

Treatments: Drug: Narcotic group regimen; Drug: Non-narcotic group regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT03640247

IRB18-00412

Details and patient eligibility

About

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

Full 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

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Narcotic group regimen

Other group

Description:

* 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.

Treatment:

Drug: Narcotic group regimen

Non-narcotic group regimen

Active Comparator group

Description:

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

Treatment:

Drug: Non-narcotic group regimen