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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04290208
• Other study ID #: F/N-R19-3892BLP
• Status: Recruiting
• Phase: Phase 4
• Start date: August 22, 2019
• Est. completion date: June 23, 2020

Study information

• Verified date: February 2020
• Source: Main Line Health
• Contact: Dmitri Chamchad, MD
• Phone: 610-355-9451
• Email: chamchad[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 23, 2020
• Est. primary completion date: June 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acetaminophen
• Cesarean Section
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Acetaminophen
IV Acetaminophen
• Acetaminophen
Acetaminophen liquid syrup
• Placebos
Flavored, non-medicated (placebo) liquid syrup
• Placebos
IV salt solution (non-medicated)

Locations

Country	Name	City	State
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Main Line Health	Sharpe-Strumia Research Foundation

Country where clinical trial is conducted

United States, 

References & 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. Review. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Every hour for six hours post-op
Secondary	Patient Satisfaction	Patient satisfaction will be assessed using the validated survey used in the Mayo Clinical Trial.	Up to 24 hours
Secondary	Postoperative complications during the inpatient stay	Postoperative complications will be noted during the inpatient stay.	Up to 24 hours