Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- MetroHealth Medical Center
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Overall mean pain as assessed by 10 point visual analogue scale from the 6 post operative day time points.
Study Overview
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.
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):
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
All party or parties involved have knowledge of the interventions assigned to individual participants
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Narcotic group regimen (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
Intervention: Non-narcotic group regimen (Drug)
Outcomes
Primary Outcomes
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
- 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))
- 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))
- 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))
Investigators
Christopher McHenry
MD, Director, Division of General Surgery
MetroHealth Medical Center