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

Phase 4

Completed

• Conditions: Opioid Use; Pain, Postoperative
• Interventions: Drug: Ibuprofen; Drug: Acetaminophen; Drug: Norco

• Registration Number: NCT03372382
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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 Timeline

• Study First Submitted: 2017-12-09
• Study First Submitted QC: 2017-12-09
• Study Start: 2017-12-13
• Study First Posted: 2017-12-13
• Primary Completion: 2018-04-10
• Study Completion: 2018-04-10
• Results First Submitted: 2019-04-04
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-13
• Last Update Submitted: 2019-06-13
• Results First Posted: 2019-07-02
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 170

Inclusion Criteria

• English or Spanish speaker women who had a cesarean section

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ibuprofen plus acetaminophen/hydrocodone	Ibuprofen	women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco)
ibuprofen plus acetaminophen	Acetaminophen	women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen
ibuprofen plus acetaminophen	Ibuprofen	women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen
ibuprofen plus acetaminophen/hydrocodone	Norco	women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco)

Primary Outcome Measures

Name	Time	Method
Pain Level	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.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	2-4 weeks postpartum	patient satisfaction as measured by the following scale: 1(very dissatisfied) 2(somewhat dissatisfied) 3(neutral) 4(satisfied) 5(very satisfied)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States