Overview

This trial is active, not recruiting.

Conditions cesarean section, pain, postoperative
Treatments iv acetaminophen, placebo
Phase phase 4
Sponsor TriHealth Inc.
Start date January 2014
End date October 2016
Trial size 116 participants
Trial identifier NCT02046382, 13068

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose supportive care
Arm
(Experimental)
Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
iv acetaminophen Ofirmev
1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
(Placebo Comparator)
Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
placebo Normal Saline
100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Primary Outcomes

Measure
Post operative pain
time frame: 48 hours

Secondary Outcomes

Measure
Narcotic associated side effects
time frame: 48 hours
Length of stay
time frame: 2-7 days

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title Randomized Control Trial of IV Acetaminophen for Post Cesarean Delivery Pain Relief
Principal investigator Donna Lambers, MD
Description See Brief Summary
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by TriHealth Inc..