ClinicalTrials.gg
Status unknownNCT05360433Updated May 4, 2022

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

A Phase 4 interventional study of Oxycodone oral capsule in Post Operative Pain, sponsored by Carilion Clinic. Status unknown at 1 site in United States. Open to female participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-04.

Sponsored by Carilion Clinic · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Nov 2020, registered Mar 2022).
Phase
Phase 4
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
19 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Post Operative Pain

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Keywords

  • cesarean section
  • opioid prescription
  • narcotics
  • opioids
  • post operative pain
03

In context

Pain, Postoperative

5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's planned enrollment of 170 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Carilion Clinic is the lead sponsor of 75 studies on the registry; 14 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 2 (22%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
170 participants (estimated)

Study arms

  • Active comparator
    10 tablet prescription group

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

    Drug: Oxycodone oral capsule

  • Active comparator
    20 tablet prescription group

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

    Drug: Oxycodone oral capsule

Interventions

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

    Also known as: opioid prescription size

06

What researchers measure

Primary outcomes

  1. Total opioid consumption by participants post-cesarean delivery

    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.

    Time frame: 2 weeks

  2. Total opioid consumption by participants post-cesarean delivery

    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.

    Time frame: 6 weeks

Secondary outcomes

  1. Participant pain rating

    reported level pain based on Numeric Pain Rating Scale (NPRS) 0-10, with 0 being no pain and 10 being the worst pain imaginable

    Time frame: 2 weeks

  2. Participant pain rating

    reported level pain based on Numeric Pain Rating Scale (NPRS) 0-10, with 0 being no pain and 10 being the worst pain imaginable

    Time frame: 6 weeks

  3. Participant satisfaction with pain management

    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

    Time frame: 2 weeks

  4. Participant satisfaction with pain management

    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

    Time frame: 6 weeks

  5. Requests for opioid prescription refills by participants

    Number of opioid refills required by participant requesting additional medication up to 6 weeks post operative

    Time frame: 2 weeks

  6. Requests for opioid prescription refills by participants

    Number of opioid refills required by participant requesting additional medication up to 6 weeks post operative

    Time frame: 6 weeks

07

Study locations

1 of 1 sites recruiting
  • Carilion Roanoke Memorial Hospital
    Roanoke, Virginia 24014, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — There is no plan to share IPD.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2020 (actual). Primary completion is estimated for Dec 2022, 25 months after the start.

Of 492 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 25 months is above that.

Counting every sponsor, half of 497 studies reached it within 15 months; a quarter within 8 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2022
First posted
May 4, 2022
StartActual
Nov 1, 2020
Primary completionEst.
Dec 1, 2022
CompletionEst.
Dec 1, 2022
Last update
May 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05360433
Lead sponsor
Carilion Clinic
Responsible party
Jaclyn D Nunziato (Assistant Professor of Obstetrics and Gynecology, Carilion Clinic) — Principal investigator
First posted
May 4, 2022
Start date
Nov 1, 2020
Primary completion
Dec 1, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
May 4, 2022

Study contacts

Robyn N Goodrich, BA
Contact
rgoodrich@vt.edu
434-825-7630
Jaclyn D Nunziato, MD
Contact
jdnunziato@carilionclinic.org
540-655-0459
Jaclyn D Nunziato, MD
principal investigator · Carilion Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Oxycodone

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