NCT04290208

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

August 22, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

August 14, 2019

Last Update Submit

February 26, 2020

Conditions

Postoperative PainCesarean SectionAcetaminophen

Keywords

HumansFemalePregnancyAcetaminophenNarcoticsPatient SatisfactionCesarean SectionPainPostoperative Period

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Post-operative Pain Level

    Every hour for six hours post-op

  • Patient Satisfaction

    Up to 24 hours

  • Postoperative complications during the inpatient stay

    Up to 24 hours

Study Arms (2)

Intravenous Administration of Acetaminophen

ACTIVE COMPARATOR

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

Drug: AcetaminophenDrug: Placebos

Per Oral Administration of Acetaminophen

ACTIVE COMPARATOR

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

Drug: AcetaminophenDrug: Placebos

Interventions

AcetaminophenDRUG

IV Acetaminophen

Also known as: Tylenol
Intravenous Administration of Acetaminophen
PlacebosDRUG

Flavored, non-medicated (placebo) liquid syrup

Also known as: Placebo for acetaminophen
Intravenous Administration of Acetaminophen

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women age 18 or older
  • Scheduled to undergo a cesarean section

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

Related Publications (2)

  • Nelson G, Kalogera E, Dowdy SC. Enhanced recovery pathways in gynecologic oncology. Gynecol Oncol. 2014 Dec;135(3):586-94. doi: 10.1016/j.ygyno.2014.10.006. Epub 2014 Oct 12.

    PMID: 25316179BACKGROUND

  • Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.

    PMID: 22524979RESULT

MeSH Terms

Conditions

Pain, PostoperativePatient SatisfactionPain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Dmitri Chamchad, MD

    Main Line Health

    PRINCIPAL INVESTIGATOR

  • Robert Day, MD

    Bryn Mawr Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitri Chamchad, MD

CONTACT

610-355-9451chamchad@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesia Research Director

Study Record Dates

First Submitted

August 14, 2019

First Posted

February 28, 2020

Study Start

August 22, 2019

Primary Completion

June 23, 2020

Study Completion

June 23, 2020

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations

US(1)