A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section
- Conditions
- Postoperative PainCesarean SectionAcetaminophen
- Interventions
- Drug: Placebos
- Registration Number
- NCT04290208
- Lead Sponsor
- Main Line Health
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 130
- Women age 18 or older
- Scheduled to undergo a cesarean section
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Per Oral Administration of Acetaminophen Placebos A pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room. Intravenous Administration of Acetaminophen Placebos A single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed. Per Oral Administration of Acetaminophen Acetaminophen A pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room. Intravenous Administration of Acetaminophen Acetaminophen A single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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).
Postoperative complications during the inpatient stay Up to 24 hours Postoperative complications will be noted during the inpatient stay.
Patient Satisfaction Up to 24 hours Patient satisfaction will be assessed using the validated survey used in the Mayo Clinical Trial.
Trial Locations
- Locations (1)
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States