Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sharpe-Strumia Research Foundation | OTHER |
Not provided
Not provided
Not provided
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.
"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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Administration of Acetaminophen | Active Comparator | A single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed. |
|
| Per Oral Administration of Acetaminophen | Active Comparator | A pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | IV Acetaminophen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmitri Chamchad, MD | Contact | 610-355-9451 | chamchad@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dmitri Chamchad, MD | Main Line Health | Principal Investigator |
| Robert Day, MD | Bryn Mawr Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lankenau Medical Center | Recruiting | Wynnewood | Pennsylvania | 19096 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25316179 | Background | 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. | |
| 22524979 | Result | 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. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D017060 | Patient Satisfaction |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| Acetaminophen | Drug | Acetaminophen liquid syrup |
|
|
| Placebos | Drug | Flavored, non-medicated (placebo) liquid syrup |
|
|
| Placebos | Drug | IV salt solution (non-medicated) |
|
|
| Patient Satisfaction |
Patient satisfaction will be assessed using the validated survey used in the Mayo Clinical Trial. |
| Up to 24 hours |
| Postoperative complications during the inpatient stay | Postoperative complications will be noted during the inpatient stay. | Up to 24 hours |
| D012816 | Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| Aniline Compounds |
| D000588 | Amines |