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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-13

Study Completion Date

2018-04-10

Brief Summary

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Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid

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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.

Conditions

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Opioid Use Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two parallel groups included, randomized to control analgesic regimen versus alternative analgesic regimen and followed prospectively.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ibuprofen plus acetaminophen

women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

NSAID

Acetaminophen

Intervention Type DRUG

analgesic

ibuprofen plus acetaminophen/hydrocodone

women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco)

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

NSAID

Norco

Intervention Type DRUG

acetaminophen plus opioid

Interventions

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Ibuprofen

NSAID

Intervention Type DRUG

Acetaminophen

analgesic

Intervention Type DRUG

Norco

acetaminophen plus opioid

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes