Back to resultsIbuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section (IVY)
Primary Purpose
Opioid Use, Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Acetaminophen
Norco
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use focused on measuring postpartum
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ibuprofen plus acetaminophen
ibuprofen plus acetaminophen/hydrocodone
Arm Description
women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen
women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient Satisfaction
patient satisfaction as measured by the following scale: 1(very dissatisfied) 2(somewhat dissatisfied) 3(neutral) 4(satisfied) 5(very satisfied)
Full Information
NCT ID
NCT03372382
First Posted
December 9, 2017
Last Updated
June 13, 2019
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03372382
Brief Title
Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section
Acronym
IVY
Official Title
Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section: A Prospective, Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
April 10, 2018 (Actual)
Study Completion Date
April 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Pain, Postoperative
Keywords
postpartum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
two parallel groups included, randomized to control analgesic regimen versus alternative analgesic regimen and followed prospectively.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ibuprofen plus acetaminophen
Arm Type
Active Comparator
Arm Description
women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen
Arm Title
ibuprofen plus acetaminophen/hydrocodone
Arm Type
Experimental
Arm Description
women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone (Norco)
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
NSAID
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
analgesic
Intervention Type
Drug
Intervention Name(s)
Norco
Intervention Description
acetaminophen plus opioid
Primary Outcome Measure Information:
Title
Pain Level
Description
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.
Time Frame
2-4 weeks postpartum
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
patient satisfaction as measured by the following scale: 1(very dissatisfied) 2(somewhat dissatisfied) 3(neutral) 4(satisfied) 5(very satisfied)
Time Frame
2-4 weeks postpartum
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
study will be conducted among subjects who delivered by cesarean section, which by definition, are only females.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenifer Dinis, MD
Organizational Affiliation
UT Houston, McGovern Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section
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