Narcotics Inpatient / Outpatient

NCT ID: NCT03728517

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-23
• Study Completion Date: 2019-01-01

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.

Conditions

Narcotic Use

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Insiyyah Patanwala

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Insiyyah Y Patanwala

Role: PRINCIPAL_INVESTIGATOR

Indiana School of Medicine

Locations

Eskenazi Health Hospital

Indianapolis, Indiana, United States

Indiana University

Indianapolis, Indiana, United States

Methodist Hospital

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1805708779

Identifier Type: -

Identifier Source: org_study_id