Opioid UsePhase 4IVYNCT03372382
Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section
A Phase 4 study testing Ibuprofen, Acetaminophen and Norco in people with Opioid Use and Pain, Postoperative, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid 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, Pain, Postoperative
- What is being tested?
- Ibuprofen, Acetaminophen and Norco
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2017to 10 Apr 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- English or Spanish speaker women who had a cesarean section
Who cannot join
- Inability or refusal to provide informed consent.
- Reported current or prior opioid or benzodiazepine use disorder, including urine drug screen positive for a non prescribed opioid or benzodiazepine upon admission or during prenatal care.
- Current treatment with methadone, buprenorphine or buprenorphine plus naloxone.
- Known alcoholism disorder.
- Severe renal or hepatic impairment.
- Known creatinine > 1.5 at the time of delivery or severe proteinuria leading to diagnosis of renal disease prior to delivery.
Show all 14Show fewer
- Severe peptic ulcer disease
- Severe asthma (if patient has asthma but has previously tolerated NSAIDS, she will be allowed to participate)
- Known CYP450/CY92D6 mutation conferring opioid ultra-rapid metabolizer status.
- Allergy to any of the study drugs (anaphylaxis).
- Incarcerated or institutionalized patients.
- Inability to follow up as outpatient in our outpatient clinic.
- wound dehiscence or infection diagnosed prior to discharge from the hospital
- wound vac placed prior to discharge from the hospital
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section: A Prospective, Randomized Control Trial
Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid
Read the detailed description
Women will be approached priors to discharge from the hospital, if they meet inclusion criteria and consent for the study, they will be randomized to one of two possible analgesic regimens. They will be followed at 1-2 weeks and 4-6 weeks after discharge to assess pain level.
- Conditions
- Opioid Use, Pain, Postoperative
- Being tested
- Ibuprofen, Acetaminophen, Norco
- Keywords
- postpartum
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
NSAID
AcetaminophenDrug
analgesic
NorcoDrug
acetaminophen plus opioid
| Study group | Role | What they receive |
|---|---|---|
| ibuprofen plus acetaminophen | Active comparator | women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen Receives: Drug: Ibuprofen; Drug: Acetaminophen |
| ibuprofen plus acetaminophen/hydrocodone | Experimental | women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco) Receives: Drug: Ibuprofen; Drug: Norco |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
pain level measured by objective and subjective scales.
1- Objective scale: visual analogue pain score (VAS). It is a 100 mm line, patients will be instructed to mark a point in the line that represents their pain level. A point towards the left will mean "less pain" and a point towards the right will mean "more pain". After the patient makes a selection, the research team will measure where the selected point is (in cm). minimum measurement =0mm = no pain. maximum measurement=100mm=worst pain.
Measured: 2-4 weeks postpartum
Secondary outcomes (1)
Patient Satisfaction
patient satisfaction as measured by the following scale: 1(very dissatisfied) 2(somewhat dissatisfied) 3(neutral) 4(satisfied) 5(very satisfied)
Measured: 2-4 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start13 Dec 2017
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Model description
- two parallel groups included, randomized to control analgesic regimen versus alternative analgesic regimen and followed prospectively.
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenifer Dinis Ballestas, The University of Texas Health Science Center, Houston
- Investigators
- Jenifer Dinis, MD, Principal investigator, UT Houston, McGovern Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372382
- Sponsor's protocol ID
- HSC-MS-17-0777
- Acronym
- IVY
- Status last verified
- Jun 2019
- First submitted
- 9 Dec 2017
- Last updated
- 2 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section: A Prospective, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03372382
- Acronym / sponsor ID
- IVY / HSC-MS-17-0777
- Conditions
- Opioid Use, Pain, Postoperative
- Keywords
- postpartum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid
Detailed description
Women will be approached priors to discharge from the hospital, if they meet inclusion criteria and consent for the study, they will be randomized to one of two possible analgesic regimens. They will be followed at 1-2 weeks and 4-6 weeks after discharge to assess pain level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two parallel groups included, randomized to control analgesic regimen versus alternative analgesic regimen and followed prospectively.
| Arm | Type | Receives |
|---|---|---|
| ibuprofen plus acetaminophen | Active comparator | Drug: Ibuprofen, Drug: Acetaminophenwomen that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen |
| ibuprofen plus acetaminophen/hydrocodone | Experimental | Drug: Ibuprofen, Drug: Norcowomen that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- English or Spanish speaker women who had a cesarean section
Key exclusion criteria (14 listed)
- Inability or refusal to provide informed consent.
- Reported current or prior opioid or benzodiazepine use disorder, including urine drug screen positive for a non prescribed opioid or benzodiazepine upon admission or during prenatal care.
- Current treatment with methadone, buprenorphine or buprenorphine plus naloxone.
- Known alcoholism disorder.
- Severe renal or hepatic impairment.
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 |
|---|---|---|
| IbuprofenNSAID | Drug | ibuprofen plus acetaminophen, ibuprofen plus acetaminophen/hydrocodone |
| Acetaminophenanalgesic | Drug | ibuprofen plus acetaminophen |
| Norcoacetaminophen plus opioid | Drug | ibuprofen plus acetaminophen/hydrocodone |
Primary outcome
Pain Level
Time frame: 2-4 weeks postpartum
pain level measured by objective and subjective scales. 1- Objective scale: visual analogue pain score (VAS). It is a 100 mm line, patients will be instructed to mark a point in the line that represents their pain level. A point towards the left will mean "less pain" and a point towards the right will mean "more pain". After the patient makes a selection, the research team will measure where the selected point is (in cm). minimum measurement =0mm = no pain. maximum measurement=100mm=worst pain.
1 secondary outcome
Patient Satisfaction
Time frame: 2-4 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Jenifer Dinis, MD principal investigator
UT Houston, McGovern Medical School
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 Ibuprofen, Acetaminophen and Norco in people with Opioid Use and Pain, Postoperative, run by The University of Texas Health Science Center, Houston 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 1 inclusion and 14 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 2 Jul 2019. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Level (time frame: 2-4 weeks postpartum). 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 2 Jul 2019.