Trial | NCT04290208  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    130
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.
"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.
Study Started
Aug 22
2019
Primary Completion
Jun 23
2020
Anticipated
Study Completion
Jun 23
2020
Anticipated
Last Update
Feb 28
2020

Drug Acetaminophen

IV Acetaminophen

  • Other names: Tylenol

Drug Acetaminophen

Acetaminophen liquid syrup

  • Other names: Tylenol

Drug Placebos

Flavored, non-medicated (placebo) liquid syrup

  • Other names: Placebo for acetaminophen

Drug Placebos

IV salt solution (non-medicated)

  • Other names: Placebo for acetaminophen

Intravenous Administration of Acetaminophen Active Comparator

A single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed.

Per Oral Administration of Acetaminophen Active Comparator

A pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room.

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
No Results Posted