Narcotics Inpatient / Outpatient

NCT03728517 | Terminated

• 1 other identifier: 1805708779
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 3

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.

Conditions

Narcotic Use

Keywords

Narcotic; Inpatient; Outpatient; Comparison

Outcome Measures

Primary Outcomes (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?

  1 year

Secondary Outcomes (1)

• Develop a model

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (3)

Eskenazi Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Insiyyah Y Patanwala

  Indiana School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 2, 2018
• Study Start: August 23, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

US (3)