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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


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 pain

Total amount of narcotic medication given during the first 48 hours post-surgery

Secondary outcome:

Narcotic associated side effects

Length of stay

Detailed description: See Brief Summary


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


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


- 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

Page last updated: August 23, 2015

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