Narcotics Inpatient / Outpatient

Sponsor

Indiana University (Other)

Overall Status

Terminated

CT.gov ID

NCT03728517

Collaborator

(none)

Enrollment

Locations

4.3

Actual Duration (Months)

1.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	Intervention/Treatment	Phase
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:

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?
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 Design

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 :

Aug 23, 2018

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge. [1 year]
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?

Secondary Outcome Measures

Develop a model [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eskenazi Health Hospital	Indianapolis	Indiana	United States	46202
2	Indiana University	Indianapolis	Indiana	United States	46202
3	Methodist Hospital	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Indiana University

Investigators

Principal Investigator: Insiyyah Y Patanwala, Indiana School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Insiyyah Patanwala, Principle Investigator, Indiana University

ClinicalTrials.gov Identifier:

NCT03728517

Other Study ID Numbers:

1805708779

First Posted:

Nov 2, 2018

Last Update Posted:

Apr 11, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Insiyyah Patanwala, Principle Investigator, Indiana University

Study Results

No Results Posted as of Apr 11, 2019