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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04290208
Other study ID # F/N-R19-3892BLP
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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