Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section

Study Overview
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Brief Summary
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Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid

Detailed Description
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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.

Official Title
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Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section: A Prospective, Randomized Control Trial

Conditions
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Opioid Use, Pain, Postoperative

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Acetaminophen
* Drug: Norco


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English or Spanish speaker women who had a cesarean section Exclusion Criteria: 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two parallel groups included, randomized to control analgesic regimen versus alternative analgesic regimen and followed prospectively.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ibuprofen plus acetaminophen<br>women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen | Drug: Ibuprofen<br>* NSAID<br>Drug: Acetaminophen<br>* analgesic<br>|
| Experimental: ibuprofen plus acetaminophen/hydrocodone<br>women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco) | Drug: Ibuprofen<br>* NSAID<br>Drug: Norco<br>* acetaminophen plus opioid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum