Too Much of a Good Thing? Impact of Initial Prescription Size in Post-cesarean Section Pain Management

NCT ID: NCT05360433

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-12-01

Brief Summary

This is a randomized controlled trial involving 170 opioid naive women ages 19-40 undergoing scheduled C-sections at Carilion Roanoke Memorial Hospital. Participants are randomized to receive either 10 or 20 tabs of oxycodone 5mg as an initial postoperative prescription in a double-blinded parallel trial design. Outcome metrics related to overall opioid consumption and patient satisfaction with pain management are collected at three different time points post-operative: 2-3 days (in hospital), 10-14 days, and 6 weeks.

Detailed Description

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

10 tablet prescription group

These participants receive 10 tablets of oxycodone 5 mg at discharge for postoperative pain.

Group Type: ACTIVE_COMPARATOR

Oxycodone oral capsule

Intervention Type: DRUG

Reduced initial prescription of oxycodone for postoperative pain management following cesarean section.

20 tablet prescription group

These participants receive 20 tablets of oxycodone 5 mg at discharge for postoperative pain.

Group Type: ACTIVE_COMPARATOR

Oxycodone oral capsule

Intervention Type: DRUG

Reduced initial prescription of oxycodone for postoperative pain management following cesarean section.

Interventions

Oxycodone oral capsule

Reduced initial prescription of oxycodone for postoperative pain management following cesarean section.

Intervention Type: DRUG

Other Intervention Names

opioid prescription size

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: collaborator

Carilion Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jaclyn D Nunziato

Assistant Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaclyn D Nunziato, MD

Role: PRINCIPAL_INVESTIGATOR

Carilion Clinic

Locations

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robyn N Goodrich, BA

Role: CONTACT

rgoodrich@vt.edu

434-825-7630

Jaclyn D Nunziato, MD

Role: CONTACT

jdnunziato@carilionclinic.org

540-655-0459

Other Identifiers

19-516

Identifier Type: -

Identifier Source: org_study_id