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

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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Opioid Use
• Intervention / Treatment: Drug: Ibuprofen; Drug: Acetaminophen; Drug: Norco

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 Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ibuprofen plus acetaminophen; women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen	Drug: Ibuprofen; NSAID; Drug: Acetaminophen; analgesic
Experimental: ibuprofen plus acetaminophen/hydrocodone; women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco)	Drug: Ibuprofen; NSAID; Drug: Norco; acetaminophen plus opioid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Jenifer Dinis, MD, UT Houston, McGovern Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2017
• Primary Completion (Actual): April 10, 2018
• Study Completion (Actual): April 10, 2018

Study Registration Dates

• First Submitted: December 9, 2017
• First Submitted That Met QC Criteria: December 9, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: postpartum
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: HSC-MS-17-0777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No