A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section

Study Overview
=================
Brief Summary
-----------------
This randomized controlled study will compare narcotic consumption between two groups: patients that receive a perioperative dose of IV acetaminophen versus patients that receive a perioperative dose of oral liquid acetaminophen for scheduled cesarean section.

Detailed Description
-----------------
Enhanced recovery is an alternate management protocol described by a multi-modal, evidence based approach to peri-operative care, with the goal of accelerating recovery and return to normal activity after surgery. Results have shown stable pain control with a decrease in narcotic consumption, a quicker return of bowel function, and decreased length of hospital stay and cost with no change in level of patient satisfaction, morbidity, or readmission rate. An aspect of some alternate management protocols is the administration of acetaminophen. The concentration of acetaminophen in cerebrospinal fluid (CSF) is directly proportional to the analgesic activity of acetaminophen. Acetaminophen relies on a high concentration gradient from the plasma to the CSF in order to passively diffuse into the central nervous system (CNS), its principal site of action. A 2012 study, comparing plasma and CSF pharmacokinetics of intravenous (IV), oral (PO), or rectal (PR) acetaminophen, concluded that IV administration of acetaminophen results in higher plasma and CSF concentration values. Therefore, IV acetaminophen produces better CNS penetration compared to PO or PR methods.

Official Title
-----------------
A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section

Conditions
-----------------
Postoperative Pain, Cesarean Section, Acetaminophen

Intervention / Treatment
-----------------
* Drug: Acetaminophen
* Drug: Acetaminophen
* Drug: Placebos
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women age 18 or older Scheduled to undergo a cesarean section Exclusion Criteria: Existing diagnosis of chronic pain Need to undergo a vertical skin incision Aspartate Aminotransferase (AST) > 50, alanine aminotransferase (ALT) > 70 Platelets below 80,000 on admission Need to undergo general anesthesia Tubal ligation at time of Cesarean section Prior or known allergy to any of the medications being utilized in this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous Administration of Acetaminophen<br>A single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed. | Drug: Acetaminophen<br>* IV Acetaminophen<br>* Other names: Tylenol;Drug: Placebos<br>* Flavored, non-medicated (placebo) liquid syrup<br>* Other names: Placebo for acetaminophen;|
| Active Comparator: Per Oral Administration of Acetaminophen<br>A pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room. | Drug: Acetaminophen<br>* Acetaminophen liquid syrup<br>* Other names: Tylenol;Drug: Placebos<br>* IV salt solution (non-medicated)<br>* Other names: Placebo for acetaminophen;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic Utilization | The Center for Disease Control and Prevention Morphine Milligram Equivalent Score will be used to calculate total narcotic use (conversion factor for administered opioid x milligrams administered) while the patient remains as an inpatient. | 6 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain Level | Pain will be measured via the visual analog Postoperative Pain Scale and gathered by nursing. The visual analogue Postoperative Pain Scale indicates the level of pain the patient is feeling or felt in the indicated period from 0 (no pain) to 100 (the worst pain possible). | Every hour for six hours post-op | 
| Patient Satisfaction | Patient satisfaction will be assessed using the validated survey used in the Mayo Clinical Trial. | Up to 24 hours | 
| Postoperative complications during the inpatient stay | Postoperative complications will be noted during the inpatient stay. | Up to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Humans, Female, Pregnancy, Acetaminophen, Narcotics, Patient Satisfaction, Cesarean Section, Pain, Postoperative Period