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

Last updated: February 26, 2020
Sponsor: Main Line Health
Overall Status: Active - Recruiting

Phase

4

Condition

Post-surgical Pain

Chronic Pain

Pain

Treatment

N/A

Clinical Study ID

NCT04290208
F/N-R19-3892BLP
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women age 18 or older

  • Scheduled to undergo a cesarean section

Exclusion

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

Study Design

Total Participants: 130
Study Start date:
August 22, 2019
Estimated Completion Date:
June 23, 2020

Study 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.

Connect with a study center

  • Lankenau Medical Center

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

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