Acetaminophen, Cesarean Section, Postoperative Pain
Conditions
Keywords
Humans, Female, Pregnancy, Acetaminophen, Narcotics, Patient Satisfaction, Cesarean Section, Pain, Postoperative Period
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.
Interventions
DRUGAcetaminophen
IV Acetaminophen
DRUGPlacebos
Flavored, non-medicated (placebo) liquid syrup
Sponsors
Sharpe-Strumia Research Foundation
Main Line Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
When the Principal Investigator calls to enroll patient into the study, pharmacy will be responsible for labelling and delivering the drugs to the labor and delivery unit. The label will include the patient enrollment number and the study name. The investigators will be blind to the patient's drug/placebo assignment. In case of emergency, side effects, or allergic reaction, the pharmacy will be contacted to unblind medication.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactDmitri Chamchad, MD
Outcome results
None listed