RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief
Information source: TriHealth Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cesarean Section; Pain, Postoperative
Intervention: IV Acetaminophen (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: TriHealth Inc. Official(s) and/or principal investigator(s): Donna Lambers, MD, Principal Investigator, Affiliation: TriHealth Inc.
Overall contact: Donna Lambers, MD, Email: donna_lambers@trihealth.com
Summary
This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen
among cesarean section patients. The study hopes to find out if patients who receive
scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain
scores and use less narcotic pain medication than patients who do not receive IV
acetaminophen.
Clinical Details
Official title: Randomized Control Trial of IV Acetaminophen for Post Cesarean Delivery Pain Relief
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Primary outcome: Post operative painTotal amount of narcotic medication given during the first 48 hours post-surgery
Secondary outcome: Narcotic associated side effectsLength of stay
Detailed description:
See Brief Summary
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Age greater than or equal to 18 years
- Scheduled cesarean section delivery
- Patient of TriHealth's Faculty Medical Center or Tri-State Maternal Fetal Medicine
Associates
- Singleton pregnancy
- Term delivery (greater than or equal to 37 weeks)
- Spinal/epidural anesthesia with epidural analgesia (duramorph)
- Use of pfannenstiel incision
Exclusion Criteria:
- Weight less than 50 kg
- Allergy to study drugs (acetaminophen, oxycodone, duramorph, NSAIDS)
- Multiple gestation pregnancy
- Cesarean section for pre-term delivery (less than 37 weeks)
- Fetal anomalies
- Inability to use epidural duramorph at time of procedure
- General anesthesia used
- Vertical skin incision
- Opioid addiction
- Liver dysfunction (hepatitis, HELLP (hemolysis, elevated liver enzymes, and low
platelet count), preeclampsia)
Locations and Contacts
Donna Lambers, MD, Email: donna_lambers@trihealth.com
TriHealth Good Samaritan Hospital, Cincinnati, Ohio 45220, United States; Recruiting Michaela Eschenbacher, MPH, Email: michaela_eschenbacher@trihealth.com
Additional Information
Starting date: January 2014
Last updated: February 5, 2015
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