Clinical trial NCT03728517: Narcotics Inpatient / Outpatient
Official title: Comparison of Inpatient Narcotics Use to Outpatient Prescription Narcotics Post-operatively
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Narcotic Use
Keywords: Narcotic
Inpatient
Outpatient
Comparison
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are 18 years old or older who will have a vaginal , laparoscopic, or robotic surgery who require observation of an inpatient stay post-operatively.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.
timeFrame: 1 year
Secondary outcomes:
measure: Develop a model
timeFrame: 1 year
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana School of Medicine
name: Insiyyah Y Patanwala
role: PRINCIPAL_INVESTIGATOR
References: