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

NCT03372382 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-17-0777
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Opioid Use; Pain, Postoperative

Keywords

postpartum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Satisfaction

  2-4 weeks postpartum

Study Arms (2)

ibuprofen plus acetaminophen

ACTIVE COMPARATOR

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

Drug: Ibuprofen; Drug: Acetaminophen

ibuprofen plus acetaminophen/hydrocodone

EXPERIMENTAL

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

Drug: Ibuprofen; Drug: Norco

Interventions

Ibuprofen DRUG

NSAID

ibuprofen plus acetaminophen; ibuprofen plus acetaminophen/hydrocodone

Acetaminophen DRUG

analgesic

ibuprofen plus acetaminophen

Norco DRUG

acetaminophen plus opioid

ibuprofen plus acetaminophen/hydrocodone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: study will be conducted among subjects who delivered by cesarean section, which by definition, are only females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English or Spanish speaker women who had a cesarean section

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen; Acetaminophen; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr Jenifer Dinis, MD
• Organization: McGovern Medical School, University of Texas, Health Science Center at Houston

jenifer.dinis@uth.tmc.edu

713 500 6421

Study Officials

• Jenifer Dinis, MD

  UT Houston, McGovern Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Maternal Fetal Medicine Fellow

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

Study Record Dates

• First Submitted: December 9, 2017
• First Posted: December 13, 2017
• Study Start: December 13, 2017
• Primary Completion: April 10, 2018
• Study Completion: April 10, 2018
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06

Locations

US (1)