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

February 26, 2020 updated by: Dmitri Chamchad, Main Line Health
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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: 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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic Utilization
Time Frame: 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.
6 hours post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Pain Level
Time Frame: 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).
Every hour for six hours post-op
Patient Satisfaction
Time Frame: Up to 24 hours
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
Time Frame: Up to 24 hours
Postoperative complications will be noted during the inpatient stay.
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Main Line Health

Collaborators

Sharpe-Strumia Research Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2019

Primary Completion (Anticipated)

June 23, 2020

Study Completion (Anticipated)

June 23, 2020

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

February 26, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F/N-R19-3892BLP

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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