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Completed

NCT Number: NCT03372382

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

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

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

NSAID

Acetaminophen

Drug

analgesic

Norco

Drug

acetaminophen plus opioid

Primary outcomes

  1. Pain Level

    Time frame: 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 outcomes

  1. Patient Satisfaction

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Acronym: IVY

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2017
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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