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

Primary Purpose

Postoperative Pain, Cesarean Section, Acetaminophen

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Acetaminophen
Placebos
Placebos
Sponsored by
Main Line Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Humans, Female, Pregnancy, Acetaminophen, Narcotics, Patient Satisfaction, Cesarean Section, Pain, Postoperative Period

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Lankenau Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intravenous Administration of Acetaminophen

Per Oral Administration of Acetaminophen

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Post-operative Pain Level
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).
Patient Satisfaction
Patient satisfaction will be assessed using the validated survey used in the Mayo Clinical Trial.
Postoperative complications during the inpatient stay
Postoperative complications will be noted during the inpatient stay.

Full Information

First Posted
August 14, 2019
Last Updated
February 26, 2020
Sponsor
Main Line Health
Collaborators
Sharpe-Strumia Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04290208
Brief Title
A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section
Official Title
A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
June 23, 2020 (Anticipated)
Study Completion Date
June 23, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Main Line Health
Collaborators
Sharpe-Strumia Research Foundation

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Cesarean Section, Acetaminophen
Keywords
Humans, Female, Pregnancy, Acetaminophen, Narcotics, Patient Satisfaction, Cesarean Section, Pain, Postoperative Period

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Administration of Acetaminophen
Arm Type
Active Comparator
Arm Description
A single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed.
Arm Title
Per Oral Administration of Acetaminophen
Arm Type
Active Comparator
Arm Description
A pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
IV Acetaminophen
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
Acetaminophen liquid syrup
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Placebo for acetaminophen
Intervention Description
Flavored, non-medicated (placebo) liquid syrup
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Placebo for acetaminophen
Intervention Description
IV salt solution (non-medicated)
Primary Outcome Measure Information:
Title
Narcotic Utilization
Description
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.
Time Frame
6 hours post operative
Secondary Outcome Measure Information:
Title
Post-operative Pain Level
Description
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).
Time Frame
Every hour for six hours post-op
Title
Patient Satisfaction
Description
Patient satisfaction will be assessed using the validated survey used in the Mayo Clinical Trial.
Time Frame
Up to 24 hours
Title
Postoperative complications during the inpatient stay
Description
Postoperative complications will be noted during the inpatient stay.
Time Frame
Up to 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitri Chamchad, MD
Phone
610-355-9451
Email
chamchad@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitri Chamchad, MD
Organizational Affiliation
Main Line Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Day, MD
Organizational Affiliation
Bryn Mawr Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derek Bowden
Phone
484-476-2692
Email
Dbowden@mlhs.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
25316179
Citation
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.
Results Reference
background
PubMed Identifier
22524979
Citation
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.
Results Reference
result

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

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