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

Study Overview
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Brief Summary
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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.

Detailed Description
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See Brief Summary

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

Conditions
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Cesarean Section, Pain, Postoperative

Intervention / Treatment
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* Drug: IV Acetaminophen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Acetaminophen<br>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. | Drug: IV Acetaminophen<br>* 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.<br>* Other names: Ofirmev;|
| Placebo Comparator: Normal Saline<br>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. | Drug: Placebo<br>* 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.<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Oxycodone (mg) | Total oxycodone (mg) for breakthrough pain during inpatient stay | approximately 2 - 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Narcotic Associated Side Effects | Only outcome for nausea/emesis is reported. | 2-7 days | 
| Length of Stay | Length of hospital stay (admission to discharge) will be collected. | 2-7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV Acetaminophen, Cesarean Section, Pain, Postoperative