Narcotics Inpatient / Outpatient

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

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.

Study Overview

• Status: Terminated
• Conditions: Narcotic Use

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.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
    • Indianapolis, Indiana, United States, 46202
      • Methodist Hospital
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Subjects who undergo gynecologic surgery; Subjects who will undergo gynecologic surgery via vaginally, laparoscopic , or robotic who require observation or inpatient stay overnight. This group will receive pain medication in the hospital and will also be discharged home with pain medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.	Is opioid consumption during the immediate postoperative recovery phase associated with consumption after discharge?; Are variables that are known to be associated with opioid consumption, also associated with opioid consumption after discharge?; Are there factors which we can use to predict opioid consumption in postoperative patients?	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop a model	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.	1 year

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Insiyyah Y Patanwala, Indiana School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Outpatient; Inpatient; Comparison; Narcotic
• Other Study ID Numbers: 1805708779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No