A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Intravenous Administration of Acetaminophen A single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed. |
Drug: Acetaminophen
IV Acetaminophen
Other Names:
Drug: Placebos
Flavored, non-medicated (placebo) liquid syrup
Other Names:
|
Active Comparator: Per Oral Administration of Acetaminophen A pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room. |
Drug: Acetaminophen
Acetaminophen liquid syrup
Other Names:
Drug: Placebos
IV salt solution (non-medicated)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Narcotic Utilization [6 hours post operative]
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 [Every hour for six hours post-op]
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 [Up to 24 hours]
Patient satisfaction will be assessed using the validated survey used in the Mayo Clinical Trial.
- Postoperative complications during the inpatient stay [Up to 24 hours]
Postoperative complications will be noted during the inpatient stay.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Lankenau Medical Center | Wynnewood | Pennsylvania | United States | 19096 |
Sponsors and Collaborators
- Main Line Health
- Sharpe-Strumia Research Foundation
Investigators
- Principal Investigator: Dmitri Chamchad, MD, Main Line Health
- Principal Investigator: Robert Day, MD, Bryn Mawr Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- F/N-R19-3892BLP