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

Sponsor
Main Line Health (Other)
Overall Status
Unknown status
CT.gov ID
NCT04290208
Collaborator
Sharpe-Strumia Research Foundation (Other)
130
1
2
10.1
12.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
When the Principal Investigator calls to enroll patient into the study, pharmacy will be responsible for labelling and delivering the drugs to the labor and delivery unit. The label will include the patient enrollment number and the study name. The investigators will be blind to the patient's drug/placebo assignment. In case of emergency, side effects, or allergic reaction, the pharmacy will be contacted to unblind medication.
Primary Purpose:
Treatment
Official Title:
A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section
Actual Study Start Date :
Aug 22, 2019
Anticipated Primary Completion Date :
Jun 23, 2020
Anticipated Study Completion Date :
Jun 23, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intravenous Administration of Acetaminophen

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

Drug: Acetaminophen
IV Acetaminophen
Other Names:
  • Tylenol
  • Drug: Placebos
    Flavored, non-medicated (placebo) liquid syrup
    Other Names:
  • Placebo for acetaminophen
  • Active Comparator: Per Oral Administration of Acetaminophen

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

    Drug: Acetaminophen
    Acetaminophen liquid syrup
    Other Names:
  • Tylenol
  • Drug: Placebos
    IV salt solution (non-medicated)
    Other Names:
  • Placebo for acetaminophen
  • Outcome Measures

    Primary Outcome Measures

    1. Narcotic Utilization [6 hours post operative]

      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.

    Secondary Outcome Measures

    1. Post-operative Pain Level [Every hour for six hours post-op]

      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).

    2. Patient Satisfaction [Up to 24 hours]

      Patient satisfaction will be assessed using the validated survey used in the Mayo Clinical Trial.

    3. Postoperative complications during the inpatient stay [Up to 24 hours]

      Postoperative complications will be noted during the inpatient stay.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lankenau Medical Center Wynnewood Pennsylvania United States 19096

    Sponsors and Collaborators

    • Main Line Health
    • Sharpe-Strumia Research Foundation

    Investigators

    • Principal Investigator: Dmitri Chamchad, MD, Main Line Health
    • Principal Investigator: Robert Day, MD, Bryn Mawr Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dmitri Chamchad, Anesthesia Research Director, Main Line Health
    ClinicalTrials.gov Identifier:
    NCT04290208
    Other Study ID Numbers:
    • F/N-R19-3892BLP
    First Posted:
    Feb 28, 2020
    Last Update Posted:
    Feb 28, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Dmitri Chamchad, Anesthesia Research Director, Main Line Health
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 28, 2020