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

Pain, Postoperative Clinical Trial

— IVY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372382
• Other study ID #: HSC-MS-17-0777
• Status: Completed
• Phase: Phase 4
• Start date: December 13, 2017
• Est. completion date: April 10, 2018

Study information

• Verified date: June 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative

Intervention

Drug:
• Ibuprofen
NSAID
• Acetaminophen
analgesic
• Norco
acetaminophen plus opioid

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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