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Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ibuprofen plus acetaminophen | Active Comparator | women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen |
|
| ibuprofen plus acetaminophen/hydrocodone | Experimental | women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | NSAID |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-4 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | patient satisfaction as measured by the following scale: 1(very dissatisfied) 2(somewhat dissatisfied) 3(neutral) 4(satisfied) 5(very satisfied) | 2-4 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
study will be conducted among subjects who delivered by cesarean section, which by definition, are only females.
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| Name | Affiliation | Role |
|---|---|---|
| Jenifer Dinis, MD | UT Houston, McGovern Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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recruitment start date: 12/2017 recruitment end date: 03/2018
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen Plus Acetaminophen | women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen Ibuprofen: NSAID Acetaminophen: analgesic 85 women recruited into this study arm |
| FG001 | Ibuprofen Plus Acetaminophen/Hydrocodone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2018 |
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two parallel groups included, randomized to control analgesic regimen versus alternative analgesic regimen and followed prospectively.
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| Acetaminophen | Drug | analgesic |
|
| Norco | Drug | acetaminophen plus opioid |
|
women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone Ibuprofen: NSAID Acetaminophen plus hydrocodone: Opioid 85 women recruited into this study arm |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen Plus Acetaminophen | women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen Ibuprofen: NSAID Acetaminophen: analgesic 85 women recruited into this study arm |
| BG001 | Ibuprofen Plus Acetaminophen/Hydrocodone | women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone Ibuprofen: NSAID Acetaminophen plus hydrocodone: Opioid 85 women recruited into this study arm |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | The primary outcome was available in 71 patients in the non-opioid group and 76 patients in the opioid group. The results below are primary outcome data analyzed by intention to treat. | Posted | Mean | Standard Deviation | millimeters on a scale | 2-4 weeks postpartum |
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| Secondary | Patient Satisfaction | patient satisfaction as measured by the following scale: 1(very dissatisfied) 2(somewhat dissatisfied) 3(neutral) 4(satisfied) 5(very satisfied) | Posted | Count of Participants | Participants | 2-4 weeks postpartum |
|
|
four months
a standard questionnaire was used to assess whether any adverse events had occurred. It was administered at the time of follow up.
Medical records were also reviewed to determine if a patient had an adverse event
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibuprofen Plus Acetaminophen | women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen Ibuprofen: NSAID Acetaminophen: analgesic 85 women recruited into this study arm | 0 | 85 | 0 | 85 | 14 | 85 |
| EG001 | Ibuprofen Plus Acetaminophen/Hydrocodone | women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone Ibuprofen: NSAID Acetaminophen plus hydrocodone: Opioid 85 women recruited into this study arm | 0 | 85 | 0 | 85 | 25 | 85 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea / emesis | Gastrointestinal disorders | Systematic Assessment | non-opioid group: 2 opioid group: 5 |
| |
| constipation | Gastrointestinal disorders | Systematic Assessment | constipation |
| |
| somnolence | General disorders | Systematic Assessment | somnolence |
| |
| GERD | Gastrointestinal disorders | Systematic Assessment | reflux |
| |
| itching | General disorders | Systematic Assessment | itching |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jenifer Dinis, MD | McGovern Medical School, University of Texas, Health Science Center at Houston | 713 500 6421 | jenifer.dinis@uth.tmc.edu |
| Mar 25, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
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| Hispanic |
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| white |
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| other |
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We prespecified an equivalence margin of -10 to 10mm. We would consider non-opioid analgesia to be equivalent to opioid analgesia if the pain score mean difference between the groups and it's 95% confidence interval (CI) were within the prespecified margin. Pain score mean difference or 95% CI boundaries outside this range would be considered a clinically important difference between treatments
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