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- Klinische proef NCT05360433
Too Much of a Good Thing? Impact of Initial Prescription Size in Post-cesarean Section Pain Management
Impact of Reduced Initial Prescription Size on Opioid Consumption in Postoperative Pain Management for Scheduled Cesarean Deliveries
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
All faculty scheduled cesarean deliveries will be eligible for possible enrollment. Once patients are scheduled for delivery, their providers will grant permission for potential participation in the study. Two weeks prior to surgery, potential participants will receive a phone call to assess interest and eligibility for participation. During the phone call, investigators will explain the goals of this research project and the overall study design. If an individual expresses interest in participation during this initial phone call, investigators will administer an intake survey. The intake survey is designed to collect data on participant eligibility as well as preexisting attitudes and experiences that may influence postoperative opioid consumption.
Patients who complete the initial survey will be approached by a member of the research team on postoperative day two or three prior to discharge from the hospital. At this time, investigators will obtain informed consent and provide each participant with an enrollment packet prepared by the principal investigator. The enrollment packet will contain educational components including information about opioids with specific instructions about how to use opioids for pain management and instructions on proper disposal of unused tablets. Investigators will also include information about alternative forms of analgesia (ibuprofen and acetaminophen) with FDA approved instructions regarding their use in pain management. The study team's goal in including these educational components for each study group is to ensure that women are able to make safe and informed decisions regarding both forms of medication for optimal pain management. The enrollment packet will also include copies of all surveys the participants will be completing and a visual representation of the numerical pain scale for participants to reference.
Women in the study will be randomized to receive either 10 or 20 tablets of oxycodone 5 mg upon discharge. Randomization of prescription groups will be achieved using a computer randomized sequence assigning participants in a 1:1 ratio to either a standard discharge prescription size (20 tablets oxycodone 5mg) or a reduced initial prescription size (10 tablets oxycodone 5 mg). Participants will not be given information regarding prescription size of other participants in the study, and will therefore be blinded as to whether or not their prescription size represents the larger or smaller group.In the event that a participant should require more opioid tablets for pain medication, there will be an option to request a refill from a designated provider. Refills across both groups will be standardized to a size of 5 tablets and healthcare providers will be notified of the participant's request in order to help determine if an earlier postoperative visit is needed for evaluation.
Outcome metrics will be collected at 3 different postoperative time points. The initial "inpatient survey" will be completed in person at the time of consent on postoperative day two or three. This survey is designed to collect information about each participant's perceived pain experience during inpatient stay and capture pain rating at time of discharge. Outcome metrics at two subsequent time points (10-14 days post-op and 6 weeks post-op) will be collected using an "outpatient survey." Participants will be given the option to complete the outpatient surveys over the phone with the investigator directly inputting metrics or through an online survey directly linked to the study electronic database. Follow-up surveys will assess a number of outcome metrics related to opioid use, participant's pain experience, and participant satisfaction with pain management.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: Robyn N Goodrich, BA
- Telefoonnummer: 434-825-7630
- E-mail: rgoodrich@vt.edu
Studie Contact Back-up
- Naam: Jaclyn D Nunziato, MD
- Telefoonnummer: 540-655-0459
- E-mail: jdnunziato@carilionclinic.org
Studie Locaties
-
-
Virginia
-
Roanoke, Virginia, Verenigde Staten, 24014
- Werving
- Carilion Roanoke Memorial Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Female
- Age 19-40 years old
- Pregnant
- Scheduled to undergo cesarean section at Carilion Roanoke Memorial Hospital
- opioid naïve (defined as no opioid use within 30 days of surgery
Exclusion Criteria:
- History of chronic pain
- History of opioid use disorder
- History of any known intolerance or allergies to analgesics
- Women with postoperative complications (hysterectomy during or after birth, bowel or bladder injury during birth, need for re-operation, or immediate wound complication)
- Language barrier preventing screening or consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: 10 tablet prescription group
These participants receive 10 tablets of oxycodone 5 mg at discharge for postoperative pain.
|
Reduced initial prescription of oxycodone for postoperative pain management following cesarean section.
Andere namen:
|
Actieve vergelijker: 20 tablet prescription group
These participants receive 20 tablets of oxycodone 5 mg at discharge for postoperative pain.
|
Reduced initial prescription of oxycodone for postoperative pain management following cesarean section.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Total opioid consumption by participants post-cesarean delivery
Tijdsspanne: 2 weeks
|
Number of tablets of oxycodone consumed for postoperative pain management.
This will be measured by a pill count at the participant's 2 week post-op visit and the participant's responses to postoperative surveys at 2 weeks and 6 weeks post surgery.
|
2 weeks
|
Total opioid consumption by participants post-cesarean delivery
Tijdsspanne: 6 weeks
|
Number of tablets of oxycodone consumed for postoperative pain management.
This will be measured by a pill count at the participant's 2 week post-op visit and the participant's responses to postoperative surveys at 2 weeks and 6 weeks post surgery.
|
6 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Participant pain rating
Tijdsspanne: 2 weeks
|
reported level pain based on Numeric Pain Rating Scale (NPRS) 0-10, with 0 being no pain and 10 being the worst pain imaginable
|
2 weeks
|
Participant pain rating
Tijdsspanne: 6 weeks
|
reported level pain based on Numeric Pain Rating Scale (NPRS) 0-10, with 0 being no pain and 10 being the worst pain imaginable
|
6 weeks
|
Participant satisfaction with pain management
Tijdsspanne: 2 weeks
|
Patient reported satisfaction with postoperative pain management on survey based on opinion of whether medications provided were strong enough and the quantity of medication provided Participants are asked "were you overall satisfied with your pain management since surgery" and answer yes or no
|
2 weeks
|
Participant satisfaction with pain management
Tijdsspanne: 6 weeks
|
Patient reported satisfaction with postoperative pain management on survey based on opinion of whether medications provided were strong enough and the quantity of medication provided Participants are asked "were you overall satisfied with your pain management since surgery" and answer yes or no
|
6 weeks
|
Requests for opioid prescription refills by participants
Tijdsspanne: 2 weeks
|
Number of opioid refills required by participant requesting additional medication up to 6 weeks post operative
|
2 weeks
|
Requests for opioid prescription refills by participants
Tijdsspanne: 6 weeks
|
Number of opioid refills required by participant requesting additional medication up to 6 weeks post operative
|
6 weeks
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jaclyn D Nunziato, MD, Carilion Clinic
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Postoperatieve complicaties
- Pijn
- Neurologische manifestaties
- Pijn, postoperatief
- Fysiologische effecten van medicijnen
- Depressiva van het centrale zenuwstelsel
- Agenten van het perifere zenuwstelsel
- Pijnstillers
- Sensorische systeemagenten
- Pijnstillers, opioïden
- Verdovende middelen
- Oxycodon
Andere studie-ID-nummers
- 19-516
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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