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Narcotics Inpatient / Outpatient

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ClinicalTrials.gov Identifier: NCT03728517
Recruitment Status : Terminated (Low recruitment)
First Posted : November 2, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Insiyyah Patanwala, Indiana University

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.


Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Inpatient Narcotics Use to Outpatient Prescription Narcotics Post-operatively
Actual Study Start Date : August 23, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

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.



Primary Outcome Measures :
  1. Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge. [ Time Frame: 1 year ]
    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?


Secondary Outcome Measures :
  1. Develop a model [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728517


Locations
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United States, Indiana
Eskenazi Health Hospital
Indianapolis, Indiana, United States, 46202
Indiana University
Indianapolis, Indiana, United States, 46202
Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Insiyyah Y Patanwala Indiana School of Medicine
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Responsible Party: Insiyyah Patanwala, Principle Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT03728517    
Other Study ID Numbers: 1805708779
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Insiyyah Patanwala, Indiana University:
Narcotic
Inpatient
Outpatient
Comparison