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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05360433
Recruitment Status : Recruiting
First Posted : May 4, 2022
Last Update Posted : May 4, 2022
Sponsor:
Collaborator:
Virginia Polytechnic Institute and State University
Information provided by (Responsible Party):
Jaclyn D Nunziato, Carilion Clinic

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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: Oxycodone oral capsule Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Reduced Initial Prescription Size on Opioid Consumption in Postoperative Pain Management for Scheduled Cesarean Deliveries
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 10 tablet prescription group
These participants receive 10 tablets of oxycodone 5 mg at discharge for postoperative pain.
Drug: Oxycodone oral capsule
Reduced initial prescription of oxycodone for postoperative pain management following cesarean section.
Other Name: opioid prescription size

Active Comparator: 20 tablet prescription group
These participants receive 20 tablets of oxycodone 5 mg at discharge for postoperative pain.
Drug: Oxycodone oral capsule
Reduced initial prescription of oxycodone for postoperative pain management following cesarean section.
Other Name: opioid prescription size




Primary Outcome Measures :
  1. Total opioid consumption by participants post-cesarean delivery [ Time Frame: 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. Total opioid consumption by participants post-cesarean delivery [ Time Frame: 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.


Secondary Outcome Measures :
  1. Participant pain rating [ Time Frame: 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. Participant pain rating [ Time Frame: 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

  3. Participant satisfaction with pain management [ Time Frame: 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

  4. Participant satisfaction with pain management [ Time Frame: 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

  5. Requests for opioid prescription refills by participants [ Time Frame: 2 weeks ]
    Number of opioid refills required by participant requesting additional medication up to 6 weeks post operative

  6. Requests for opioid prescription refills by participants [ Time Frame: 6 weeks ]
    Number of opioid refills required by participant requesting additional medication up to 6 weeks post operative



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05360433


Contacts
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Contact: Robyn N Goodrich, BA 434-825-7630 rgoodrich@vt.edu
Contact: Jaclyn D Nunziato, MD 540-655-0459 jdnunziato@carilionclinic.org

Locations
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United States, Virginia
Carilion Roanoke Memorial Hospital Recruiting
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
Carilion Clinic
Virginia Polytechnic Institute and State University
Investigators
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Principal Investigator: Jaclyn D Nunziato, MD Carilion Clinic
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Responsible Party: Jaclyn D Nunziato, Assistant Professor of Obstetrics and Gynecology, Carilion Clinic
ClinicalTrials.gov Identifier: NCT05360433    
Other Study ID Numbers: 19-516
First Posted: May 4, 2022    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jaclyn D Nunziato, Carilion Clinic:
cesarean section
opioid prescription
narcotics
opioids
post operative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents