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

NCT ID: NCT04290208

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2020-06-23

Brief Summary

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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

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"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.

Conditions

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Postoperative Pain Cesarean Section Acetaminophen

Keywords

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Humans Female Pregnancy Acetaminophen Narcotics Patient Satisfaction Cesarean Section Pain Postoperative Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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Intravenous Administration of Acetaminophen

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

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

IV Acetaminophen

Placebos

Intervention Type DRUG

Flavored, non-medicated (placebo) liquid syrup

Per Oral Administration of Acetaminophen

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

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Acetaminophen liquid syrup

Placebos

Intervention Type DRUG

IV salt solution (non-medicated)

Interventions

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Acetaminophen

IV Acetaminophen

Intervention Type DRUG

Acetaminophen

Acetaminophen liquid syrup

Intervention Type DRUG

Placebos

Flavored, non-medicated (placebo) liquid syrup

Intervention Type DRUG

Placebos

IV salt solution (non-medicated)

Intervention Type DRUG

Other Intervention Names

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Tylenol Tylenol Placebo for acetaminophen Placebo for acetaminophen

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sharpe-Strumia Research Foundation

OTHER

Sponsor Role collaborator

Main Line Health

OTHER

Sponsor Role lead

Responsible Party

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Dmitri Chamchad

Anesthesia Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dmitri Chamchad, MD

Role: PRINCIPAL_INVESTIGATOR

Main Line Health

Robert Day, MD

Role: PRINCIPAL_INVESTIGATOR

Bryn Mawr Hospital

Locations

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Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dmitri Chamchad, MD

Role: CONTACT

Phone: 610-355-9451

Email: [email protected]

Facility Contacts

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Derek Bowden

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25316179 (View on PubMed)

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.

Reference Type RESULT
PMID: 22524979 (View on PubMed)

Other Identifiers

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F/N-R19-3892BLP

Identifier Type: -

Identifier Source: org_study_id