Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section (IVY)

The University of Texas System (UT)

Status and phase

Completed

Phase 4

Conditions

Pain, Postoperative

Opioid Use

Treatments

Drug: Acetaminophen

Drug: Ibuprofen

Drug: Norco

Study type

Interventional

Funder types

Other

Identifiers

NCT03372382

HSC-MS-17-0777

Details and patient eligibility

About

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

Full 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.

Enrollment

170 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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