Post Operative PainPhase 4NCT05360433
Too Much of a Good Thing? Impact of Initial Prescription Size in Post-cesarean Section Pain Management
A Phase 4 study testing Oxycodone oral capsule in people with Post Operative Pain, run by Carilion Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Oxycodone oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 1 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
About this study
Official title: Impact of Reduced Initial Prescription Size on Opioid Consumption in Postoperative Pain Management for Scheduled Cesarean Deliveries
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.
- Conditions
- Post Operative Pain
- Being tested
- Oxycodone oral capsule
- Keywords
- cesarean section, opioid prescription, narcotics, opioids, post operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone oral capsuleDrug
Also called opioid prescription size
Reduced initial prescription of oxycodone for postoperative pain management following cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| 10 tablet prescription group | Active comparator | These participants receive 10 tablets of oxycodone 5 mg at discharge for postoperative pain. Receives: Drug: Oxycodone oral capsule |
| 20 tablet prescription group | Active comparator | These participants receive 20 tablets of oxycodone 5 mg at discharge for postoperative pain. Receives: Drug: Oxycodone oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
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.
Measured: 6 weeks
Secondary outcomes (6)
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
Measured: 2 weeks
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
Measured: 6 weeks
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
Measured: 2 weeks
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
Measured: 6 weeks
Requests for opioid prescription refills by participants
Number of opioid refills required by participant requesting additional medication up to 6 weeks post operative
Measured: 2 weeks
Requests for opioid prescription refills by participants
Number of opioid refills required by participant requesting additional medication up to 6 weeks post operative
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Nov 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Principal investigator, Jaclyn D Nunziato, Carilion Clinic
- Investigators
- Jaclyn D Nunziato, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360433
- Sponsor's protocol ID
- 19-516
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reduced Initial Prescription Size on Opioid Consumption in Postoperative Pain Management for Scheduled Cesarean Deliveries
- ClinicalTrials.gov ID
- NCT05360433
- Acronym / sponsor ID
- 19-516
- Conditions
- Post Operative Pain
- Keywords
- cesarean section, opioid prescription, narcotics, opioids, post operative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 tablet prescription group | Active comparator | Drug: Oxycodone oral capsuleThese participants receive 10 tablets of oxycodone 5 mg at discharge for postoperative pain. |
| 20 tablet prescription group | Active comparator | Drug: Oxycodone oral capsuleThese participants receive 20 tablets of oxycodone 5 mg at discharge for postoperative pain. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone oral capsuleAlso: opioid prescription sizeReduced initial prescription of oxycodone for postoperative pain management following cesarean section. | Drug | 10 tablet prescription group, 20 tablet prescription group |
Primary outcome
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.
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.
6 secondary outcomes
Participant pain rating
Time frame: 2 weeks
Participant pain rating
Time frame: 6 weeks
Participant satisfaction with pain management
Time frame: 2 weeks
Participant satisfaction with pain management
Time frame: 6 weeks
Requests for opioid prescription refills by participants
Time frame: 2 weeks
Requests for opioid prescription refills by participants
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaclyn D Nunziato, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone oral capsule in people with Post Operative Pain, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robyn N Goodrich, BA (434-825-7630, rgoodrich@vt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption by participants post-cesarean delivery (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.