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Opioid Use After Thyroid and Parathyroid Surgeries

Optimization of Opioid Discharge Prescriptions Following Thyroid and Parathyroid Surgeries

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04955444
Enrollment
240
Registered
2021-07-08
Start date
2021-06-14
Completion date
2021-12-31
Last updated
2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Pain, Postoperative, Parathyroidectomy, Thyroidectomy

Keywords

Thyroidectomy, Parathyroidectomy, Opioid, Postoperative pain, Multimodal anesthesia

Brief summary

Unnecessary opioid prescriptions for postoperative pain can increase the risk for new, persistent opioid use and dependence. Published literature suggests that most patients undergoing thyroid or parathyroid surgery can have their pain effectively managed without opioids following hospital discharge. The purpose of this quasi-experimental, quality improvement study is to develop, implement, and measure the impact of a quality improvement bundle that consists of (1) patient education, (2) provider education, and (3) electronic health record (EHR) enhancements. The proportion of patients who receive new opioid discharge prescriptions for pain management following thyroid or parathyroid surgery at Houston Methodist Hospital for up to 6 months following bundle implementation will be compared to a historical control group.

Detailed description

BACKGROUND: New and persistent opioid use after minor and major surgery is common, and the duration of opioid use following surgery is associated with opioid dependence, abuse, and overdose. Most patients undergoing thyroid or parathyroid surgery do not require opioid discharge prescriptions for effective pain management. If opioids are prescribed for these surgeries, up to 7% of patients will use opioids 3 to 6 months after surgery. Previously published quality programs that optimized perioperative multimodal analgesia (MMA) regimens, provider education, patient education, and shared decision making successfully reduced the proportion of patients discharged with opioid prescriptions to less than 5% following thyroid and parathyroid surgery. STUDY DESIGN: This quasi-experimental, quality improvement study compares opioid discharge prescribing practices before and after implementation of the quality improvement bundle. The quality improvement bundle includes patient education, provider education, and EHR enhancements. Patients who undergo a thyroidectomy or parathyroidectomy procedure will be included in the study. The historical control group includes patients treated prior to bundle implementation. The post-implementation group includes patients treated within 4 to 6 months following bundle implementation. The primary outcome is the proportion of patients who receive new opioid discharge prescriptions at discharge following a thyroidectomy or parathyroidectomy procedure. This outcome excludes the continuation of previous, chronic opioid therapy.

Interventions

The quality improvement bundle consists of (1) patient education, (2) provider education, and (3) EHR enhancements including order sets and best practice alerts.

Sponsors

University of Houston
CollaboratorOTHER
The Methodist Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The study consists of 2 groups: (1) the historical control group and (2) the post-implementation group. The historical control group includes 160 patients who underwent a thyroidectomy or a parathyroidectomy procedure from January 2018 to December 2019 (20 patients randomly sampled from each quarter prior to bundle implementation). The quality improvement bundle will be implemented at Houston Methodist Hospital in June 2021. The post-implementation group will include the first 80 eligible patients accrued over 4 to 6 months following bundle implementation. An estimated sample size of 80 patients in the post-implementation group and 160 patients in the historical control group will provide 80% power to detect an absolute decrease of 20% in the primary endpoint using a two-sided alpha of 0.05.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients undergoing a primary thyroidectomy or parathyroidectomy procedure at Houston Methodist Hospital during the study period. Only index surgeries during the study time frame were included.

Exclusion criteria

* Patients with a hospital length of stay after surgery \>2 days

Design outcomes

Primary

MeasureTime frameDescription
New Opioid Discharge PrescriptionsUp to 2 daysProportion of patients who receive new opioid discharge prescriptions at discharge following a thyroidectomy or parathyroidectomy procedure. This outcome excludes continuation of previous, chronic opioid therapy.

Secondary

MeasureTime frameDescription
Opioid Discharge Prescriptions Exceeding 112.5 Oral Morphine Milligram Equivalents (MMEs)Up to 2 daysProportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding the recommended dose of 112.5 oral MMEs
Opioid Discharge Prescriptions Exceeding 5 DaysUp to 2 daysProportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding 5 days of therapy
New Opioid Prescriptions From the Surgeon's Office Within 7 Days of SurgeryUp to 7 daysProportion of thyroidectomy and parathyroidectomy postoperative patients who receive new opioid prescriptions from the surgeon's office within 7 days of surgery including discharge prescriptions. This outcome excludes continuation of previous, chronic opioid therapy.
Opioid Prescriptions Exceeding 50 Oral MMEs/Day When New Discharge Prescriptions Are Added to Existing Opioid TherapyUp to 2 daysProportion of thyroidectomy and parathyroidectomy postoperative patients with opioid prescriptions exceeding 50 oral MMEs/day when new, postoperative discharge prescriptions are added to existing opioid therapy

Countries

United States

Participant flow

Participants by arm

ArmCount
Historical Control Group
The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle.
160
Post-implementation Group
The post-implementation group underwent a thyroidectomy or parathyroidectomy procedure after bundle implementation and received care that is enhanced by the quality improvement bundle. Quality improvement bundle: The quality improvement bundle consists of (1) patient education, (2) provider education, and (3) EHR enhancements including order sets and best practice alerts.
80
Total240

Baseline characteristics

CharacteristicTotalPost-implementation GroupHistorical Control Group
Age, Continuous57 years
STANDARD_DEVIATION 14
57 years
STANDARD_DEVIATION 14
56 years
STANDARD_DEVIATION 14
Ethnicity (NIH/OMB)
Hispanic or Latino
35 Participants14 Participants21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
205 Participants66 Participants139 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Opioid use within 1 week prior to surgery10 Participants2 Participants8 Participants
Race/Ethnicity, Customized
Race
Asian
16 Participants6 Participants10 Participants
Race/Ethnicity, Customized
Race
Black or African American
56 Participants23 Participants33 Participants
Race/Ethnicity, Customized
Race
Other
10 Participants2 Participants8 Participants
Race/Ethnicity, Customized
Race
White
158 Participants49 Participants109 Participants
Sex: Female, Male
Female
197 Participants65 Participants132 Participants
Sex: Female, Male
Male
43 Participants15 Participants28 Participants
Surgery performed
Parathyroidectomy
121 Participants39 Participants82 Participants
Surgery performed
Thyroidectomy
136 Participants46 Participants90 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

New Opioid Discharge Prescriptions

Proportion of patients who receive new opioid discharge prescriptions at discharge following a thyroidectomy or parathyroidectomy procedure. This outcome excludes continuation of previous, chronic opioid therapy.

Time frame: Up to 2 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Historical Control GroupNew Opioid Discharge Prescriptions128 Participants
Post-implementation GroupNew Opioid Discharge Prescriptions28 Participants
Secondary

New Opioid Prescriptions From the Surgeon's Office Within 7 Days of Surgery

Proportion of thyroidectomy and parathyroidectomy postoperative patients who receive new opioid prescriptions from the surgeon's office within 7 days of surgery including discharge prescriptions. This outcome excludes continuation of previous, chronic opioid therapy.

Time frame: Up to 7 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Historical Control GroupNew Opioid Prescriptions From the Surgeon's Office Within 7 Days of Surgery0 Participants
Post-implementation GroupNew Opioid Prescriptions From the Surgeon's Office Within 7 Days of Surgery0 Participants
Secondary

Opioid Discharge Prescriptions Exceeding 112.5 Oral Morphine Milligram Equivalents (MMEs)

Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding the recommended dose of 112.5 oral MMEs

Time frame: Up to 2 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Historical Control GroupOpioid Discharge Prescriptions Exceeding 112.5 Oral Morphine Milligram Equivalents (MMEs)52 Participants
Post-implementation GroupOpioid Discharge Prescriptions Exceeding 112.5 Oral Morphine Milligram Equivalents (MMEs)8 Participants
Secondary

Opioid Discharge Prescriptions Exceeding 5 Days

Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding 5 days of therapy

Time frame: Up to 2 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Historical Control GroupOpioid Discharge Prescriptions Exceeding 5 Days27 Participants
Post-implementation GroupOpioid Discharge Prescriptions Exceeding 5 Days5 Participants
Secondary

Opioid Prescriptions Exceeding 50 Oral MMEs/Day When New Discharge Prescriptions Are Added to Existing Opioid Therapy

Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid prescriptions exceeding 50 oral MMEs/day when new, postoperative discharge prescriptions are added to existing opioid therapy

Time frame: Up to 2 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Historical Control GroupOpioid Prescriptions Exceeding 50 Oral MMEs/Day When New Discharge Prescriptions Are Added to Existing Opioid Therapy9 Participants
Post-implementation GroupOpioid Prescriptions Exceeding 50 Oral MMEs/Day When New Discharge Prescriptions Are Added to Existing Opioid Therapy0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026