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Clinical Trials/NCT03640247
NCT03640247
Completed
Phase 1

Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy

MetroHealth Medical Center1 site in 1 country126 target enrollmentNovember 15, 2018

Overview

Phase
Phase 1
Intervention
Narcotic group regimen
Conditions
Thyroid Disease
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.
Status
Completed
Last Updated
6 years ago

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): * 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

Registry
clinicaltrials.gov
Start Date
November 15, 2018
End Date
December 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christopher McHenry

MD, Director, Division of General Surgery

MetroHealth Medical Center

Eligibility Criteria

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

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

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))

Study Sites (1)

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