Clinical trial NCT04290208: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Cesarean Section
Acetaminophen
Keywords: Humans
Female
Pregnancy
Acetaminophen
Narcotics
Patient Satisfaction
Cesarean Section
Pain
Postoperative Period
Lead sponsor: Main Line Health
Sponsor class: OTHER
Collaborators: name: Sharpe-Strumia Research Foundation
First posted: 2020-02-28
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Narcotic Utilization
timeFrame: 6 hours post operative
Secondary outcomes:
measure: Post-operative Pain Level
timeFrame: Every hour for six hours post-op
measure: Patient Satisfaction
timeFrame: Up to 24 hours
measure: Postoperative complications during the inpatient stay
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
Study officials:
affiliation: Main Line Health
name: Dmitri Chamchad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bryn Mawr Hospital
name: Robert Day, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.