Opioid Use, UnspecifiedNCT03959969
Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery
A study testing Educational video, Ibuprofen and Oxycodone in people with Opioid Use, Unspecified, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This is a randomized controlled trial assessing the utility of an educational video on pain management after a cesarean section to reduce opioid use. The educational video will be shown during the patient's postpartum stay and the amount of opioid and adjunct medications will be assessed in those who watched the video… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Unspecified
- What is being tested?
- Educational video, Ibuprofen and Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2019to 11 Jan 2020
- Phase
- Interventional
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Greater than 18 years of age
- Underwent repeat or primary C-section
- Literate in English Language
Who cannot join
- Complicated cesarean section including cesarean hysterectomy, bowel injury, bladder injury, and/or take-back
- History of opioid use disorder and/or on chronic opiates in pregnancy
- Contraindications to NSAIDS or acetaminophen
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
This is a randomized controlled trial assessing the utility of an educational video on pain management after a cesarean section to reduce opioid use. The educational video will be shown during the patient's postpartum stay and the amount of opioid and adjunct medications will be assessed in those who watched the video compared to those who received the standard of care discharge instructions without the video. Participants will be contacted 7 and 14 days after cesarean birth (post operative day number 7 and number 14) to complete a telephone survey on their overall pain management and to determine how many opioid tablets have been used.
- Conditions
- Opioid Use, Unspecified
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
An educational video on pain management after cesarean section. The educational video was put together by two general obstetrician-gynecologists, two maternal fetal medicine specialists, and a palliative care physician.
Standard of careOther
The standard of care discharge instructions for postoperative patients after cesarean section that are provided at the institution.
IbuprofenDrug
Also called Advil
Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.
OxycodoneDrug
Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.
| Study group | Role | What they receive |
|---|---|---|
| Educational Video Recipients | Experimental | Participants will be shown educational video on pain management after cesarean delivery on day of discharge. Upon discharge, participants will be given twenty tablets of oxycodone 5 mg by mouth every four hours as needed for pain and forty tablets of ibuprofen 600 mg by mouth every six hours as needed for pain. Receives: Other: Educational video; Drug: Ibuprofen; Drug: Oxycodone |
| Standard of Care Recipients | Active comparator | Participants will be given standard of care discharge instructions for pain management on day of discharge. Upon discharge, participants will be given twenty tablets of oxycodone 5 mg by mouth every four hours as needed for pain and forty tablets of ibuprofen 600 mg by mouth every six hours as needed for pain. Receives: Other: Standard of care; Drug: Ibuprofen; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oxycodone tablets used fourteen days after cesarean delivery
This is the total number of oxycodone tablets used by participants in each arm fourteen days after cesarean delivery (postpartum day number 14).
Measured: A total of 14 days after cesarean delivery (postpartum day number 14)
Secondary outcomes (8)
Pain assessment score from numeric pain intensity scale at seven days after cesarean delivery
Using an universal pain assessment tool of a numeric pain intensity scale, patients will be asked their pain score seven days after cesarean delivery (postpartum day 7). The numeric pain intensity scale is 0-10, with 0 being no pain and 10 being the worst pain possible.
Measured: 7 days after cesarean delivery (postpartum day number 7)
Adjunct medication use at seven days after cesarean delivery
This is to determine use of adjunct medications such as ibuprofen and Tylenol in the participants in both arms, seven days after cesarean delivery.
Measured: 7 days after cesarean delivery (postpartum day number 7)
Overall pain management satisfaction using Likert scale seven days after cesarean delivery
Assessment of overall pain management satisfaction seven days after cesarean delivery (postpartum day number 7) with five point Likert scale. The Likert scale ranges from extremely satisfied with pain management to extremely dissatisfied with pain management.
Measured: 7 days after cesarean delivery (postpartum day number 7)
Pain assessment score from numeric pain intensity scale at fourteen days after cesarean delivery
Using an universal pain assessment tool of a numeric pain intensity scale, patients will be asked their pain score fourteen days after cesarean delivery (postpartum day 14).The numeric pain intensity scale is 0-10, with 0 being no pain and 10 being the worst pain possible.
Measured: 14 days after cesarean delivery (postpartum day number 14)
Adjunct medication use at fourteen days after cesarean delivery
This is to determine use of adjunct medications such as ibuprofen and Tylenol in the participants in both arms, fourteen days after cesarean delivery.
Measured: 14 days after cesarean delivery (postpartum day number 14)
Overall pain management satisfaction using Likert scale fourteen days after cesarean delivery
Assessment of overall pain management satisfaction fourteen days after cesarean delivery (postpartum day number 14) with five point Likert scale. The Likert scale ranges from extremely satisfied with pain management to extremely dissatisfied with pain management.
Measured: 14 days after cesarean delivery (postpartum day number 14)
Total number of oxycodone tablets used inpatient
Total oxycodone tablets used during patient's inpatient stay after cesarean delivery.
Measured: 3 days
Number of oxycodone tablets used seven days after cesarean delivery
This is the total number of oxycodone tablets used by participants in each arm seven days after cesarean delivery (postpartum day number 7).
Measured: 7 days after cesarean delivery (postpartum day number 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start17 Jul 2019
- Primary completion28 Dec 2019
- Study completion11 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Opioid Use, UnspecifiedStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara N. Iqbal, Medstar Health Research Institute
- Investigators
- Sara Iqbal, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959969
- Sponsor's protocol ID
- STUDY00000260
- Status last verified
- Mar 2021
- First submitted
- 17 May 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prabhu M, McQuaid-Hanson E, Hopp S, Burns SM, Leffert LR, Landau R, Lauffenburger JC, Choudhry NK, Kaimal A, Bateman BT. A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):42-46. doi: 10.1097/AOG.0000000000002094.
PubMed 28594762Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.
PubMed 28594763Ismail S, Shahzad K, Shafiq F. Observational study to assess the effectiveness of postoperative pain management of patients undergoing elective cesarean section. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):36-40. doi: 10.4103/0970-9185.92432.
PubMed 22345943ACOG Committee Opinion No. 742 Summary: Postpartum Pain Management. Obstet Gynecol. 2018 Jul;132(1):252-253. doi: 10.1097/AOG.0000000000002711.
PubMed 29939935Mokhtari NB, Saeed H, Kawakita T, Huang JC, Iqbal SN. Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2021 Aug 1;138(2):253-259. doi: 10.1097/AOG.0000000000004468.
PubMed 34237764
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03959969
- Acronym / sponsor ID
- STUDY00000260
- Conditions
- Opioid Use, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 11 Jan 2020 (actual)
- First posted
- 22 May 2019 (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 assessing the utility of an educational video on pain management after a cesarean section to reduce opioid use. The educational video will be shown during the patient's postpartum stay and the amount of opioid and adjunct medications will be assessed in those who watched the video compared to those who received the standard of care discharge instructions without the video. Participants will be contacted 7 and 14 days after cesarean birth (post operative day number 7 and number 14) to complete a telephone survey on their overall pain management and to determine how many opioid tablets have been used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Video Recipients | Experimental | Other: Educational video, Drug: Ibuprofen, Drug: OxycodoneParticipants will be shown educational video on pain management after cesarean delivery on day of discharge. Upon discharge, participants will be given twenty tablets of oxycodone 5 mg by mouth every four hours as needed for pain and forty tablets of ibuprofen 600 mg by mouth every six hours as needed for pain. |
| Standard of Care Recipients | Active comparator | Other: Standard of care, Drug: Ibuprofen, Drug: OxycodoneParticipants will be given standard of care discharge instructions for pain management on day of discharge. Upon discharge, participants will be given twenty tablets of oxycodone 5 mg by mouth every four hours as needed for pain and forty tablets of ibuprofen 600 mg by mouth every six hours as needed for pain. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Greater than 18 years of age
- Underwent repeat or primary C-section
- Literate in English Language
Key exclusion criteria (3 listed)
- Complicated cesarean section including cesarean hysterectomy, bowel injury, bladder injury, and/or take-back
- History of opioid use disorder and/or on chronic opiates in pregnancy
- Contraindications to NSAIDS or acetaminophen
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 |
|---|---|---|
| Educational videoAn educational video on pain management after cesarean section. The educational video was put together by two general obstetrician-gynecologists, two maternal fetal medicine specialists, and a palliative care physician. | Other | Educational Video Recipients |
| Standard of careThe standard of care discharge instructions for postoperative patients after cesarean section that are provided at the institution. | Other | Standard of Care Recipients |
| IbuprofenAlso: AdvilPrescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain. | Drug | Educational Video Recipients, Standard of Care Recipients |
| OxycodonePrescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain. | Drug | Educational Video Recipients, Standard of Care Recipients |
Primary outcome
Number of oxycodone tablets used fourteen days after cesarean delivery
Time frame: A total of 14 days after cesarean delivery (postpartum day number 14)
This is the total number of oxycodone tablets used by participants in each arm fourteen days after cesarean delivery (postpartum day number 14).
8 secondary outcomes
Pain assessment score from numeric pain intensity scale at seven days after cesarean delivery
Time frame: 7 days after cesarean delivery (postpartum day number 7)
Adjunct medication use at seven days after cesarean delivery
Time frame: 7 days after cesarean delivery (postpartum day number 7)
Overall pain management satisfaction using Likert scale seven days after cesarean delivery
Time frame: 7 days after cesarean delivery (postpartum day number 7)
Pain assessment score from numeric pain intensity scale at fourteen days after cesarean delivery
Time frame: 14 days after cesarean delivery (postpartum day number 14)
Adjunct medication use at fourteen days after cesarean delivery
Time frame: 14 days after cesarean delivery (postpartum day number 14)
Overall pain management satisfaction using Likert scale fourteen days after cesarean delivery
Time frame: 14 days after cesarean delivery (postpartum day number 14)
Total number of oxycodone tablets used inpatient
Time frame: 3 days
Number of oxycodone tablets used seven days after cesarean delivery
Time frame: 7 days after cesarean delivery (postpartum day number 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Background: PubMed 28594762Prabhu M, McQuaid-Hanson E, Hopp S, Burns SM, Leffert LR, Landau R, Lauffenburger JC, Choudhry NK, Kaimal A, Bateman BT. A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):42-46. doi: 10.1097/AOG.0000000000002094.
- Background: PubMed 28594763Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.
- Background: PubMed 22345943Ismail S, Shahzad K, Shafiq F. Observational study to assess the effectiveness of postoperative pain management of patients undergoing elective cesarean section. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):36-40. doi: 10.4103/0970-9185.92432.
- Background: PubMed 29939935ACOG Committee Opinion No. 742 Summary: Postpartum Pain Management. Obstet Gynecol. 2018 Jul;132(1):252-253. doi: 10.1097/AOG.0000000000002711.
- Derived from this study: PubMed 34237764Mokhtari NB, Saeed H, Kawakita T, Huang JC, Iqbal SN. Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2021 Aug 1;138(2):253-259. doi: 10.1097/AOG.0000000000004468.
- Individual participant dataSharing planned: No
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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.
Sara Iqbal, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video, Ibuprofen and Oxycodone in people with Opioid Use, Unspecified, run by Medstar Health Research Institute 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 1 Apr 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oxycodone tablets used fourteen days after cesarean delivery (time frame: A total of 14 days after cesarean delivery (postpartum day number 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959969, which also lists 5 linked publications.
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 1 Apr 2021.