- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03728517
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Indiana University
-
Indianapolis, Indiana, Forente stater, 46202
- Methodist Hospital
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Indianapolis, Indiana, Forente stater, 46202
- Eskenazi Health Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.
Tidsramme: 1 year
|
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Develop a model
Tidsramme: 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.
|
1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Insiyyah Y Patanwala, Indiana School of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 1805708779
Plan for individuelle deltakerdata (IPD)
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