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Narcotics Inpatient / Outpatient

Comparison of Inpatient Narcotics Use to Outpatient Prescription Narcotics Post-operatively

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03728517
Enrollment
4
Registered
2018-11-02
Start date
2018-08-23
Completion date
2019-01-01
Last updated
2019-04-11

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

Conditions

Narcotic Use

Keywords

Narcotic, Inpatient, Outpatient, Comparison

Brief summary

Managing pain in postoperative patients presents challenges in striking a balance between achieving adequate pain control and over-prescribing opioids that have the potential to contribute to the opioid epidemic. There are no clear guidelines informing postoperative opioid prescribing in obstetrics and gynecology. The primary aim for this study are to better understand the factors that impact opioid use for pain management in gynecologic surgery patient after discharge. The second aim is to develop a model that incorporates individual patient baseline measures (e.g. anxiety, fibromyalgia score, inpatient narcotic consumption) to predict the amount of opioids needed following discharge.

Detailed description

Managing pain in postoperative patients presents challenges in striking a balance between achieving adequate pain control and over-prescribing opioids that have the potential to contribute to the opioid epidemic. There are no clear guidelines informing postoperative opioid prescribing in obstetrics and gynecology. A recent study by As-Sanie et al. demonstrated that gynecologists at a large academic medical center prescribe twice the amount of opioids than the average patient uses after hysterectomy.1 Similarly, a study completed at Vanderbilt University Medical Center showed that obstetricians were overprescribing narcotics to patients after cesarean deliveries.2 In addition to rates of opioid prescribing, other factors affect postoperative opioid consumption, including individual patient measures of anxiety, depression, and self-reported pain scores prior to surgery. Preoperative Fibromyalgia symptom scores, STAIT state anxiety scores and NRS pain expectations are independent predictors for morphine consumption following hysterectomy. There is a pressing need to better understand the factors that impact opioid use in women who undergo gynecologic surgery in order to mitigate the over-use of opioids for pain control upon discharge from the hospital. Aims: 1. Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge. 1. Is opioid consumption during the immediate postoperative recovery phase associated with consumption after discharge? 2. Are variables that are known to be associated with opioid consumption, also associated with opioid consumption after discharge? 3. Are there factors which we can use to predict opioid consumption in postoperative patients? 2. Develop a model that incorporates individual patient baseline measures (e.g. anxiety, fibromyalgia score, inpatient narcotic consumption) to predict the amount of opioids needed following discharge.

Interventions

None listed

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

Inclusion criteria

* 18 years old or older * Undergoing vaginal, laparoscopic or robotic gynecologic surgery requiring observation or inpatient stay overnight * Agree to receiving contact from research staff for follow up * Can provide two telephone numbers or a telephone number and email address

Exclusion criteria

* Unable to provide informed consent * Age \<18 * Intolerance/allergy to more than two narcotic medications * Allergy/contraindication to non-steroidal anti-inflammatory drugs (NSAIDs) * Has a diagnosed gynecologic malignancy other than Grade 1 endometrial cancer * Pregnant * Current opioid use on a regular basis (more than twice per week) * Illicit drug-use within the past 30 days

Design outcomes

Primary

MeasureTime frameDescription
Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.1 year1. Is opioid consumption during the immediate postoperative recovery phase associated with consumption after discharge? 2. Are variables that are known to be associated with opioid consumption, also associated with opioid consumption after discharge? 3. Are there factors which we can use to predict opioid consumption in postoperative patients?

Secondary

MeasureTime frameDescription
Develop a model1 year2\. Develop a model that incorporates individual patient baseline measures (e.g. anxiety, fibromyalgia score, inpatient narcotic consumption) to predict the amount of opioids needed following discharge.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026