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Completed

NCT Number: NCT02046382

RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief

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.

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Key information

Conditions

Cesarean Section Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

TriHealth Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

About this study

See Brief Summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IV acetaminophen

Drug

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.

Other names: Ofirmev

Placebo

Drug

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.

Other names: Normal Saline

Primary outcomes

  1. Total Oxycodone (mg)

    Time frame: approximately 2 - 7 days

    Total oxycodone (mg) for breakthrough pain during inpatient stay

Secondary outcomes

  1. Number of Participants With Narcotic Associated Side Effects

    Time frame: 2-7 days

    Only outcome for nausea/emesis is reported.

  2. Length of Stay

    Time frame: 2-7 days

    Length of hospital stay (admission to discharge) will be collected.

Other outcomes

  1. Total Amount of Ibuprofen During Inpatient Stay

    Time frame: 2-7 days

    Patients will have access to ibuprofen for mild to moderate pain. The amount consumed during inpatient stay will be collected.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Randomized Control Trial of IV Acetaminophen for Post Cesarean Delivery Pain Relief

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 27, 2014
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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