Postoperative Pain Clinical Trial
Official title:
A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Main Line Health | Sharpe-Strumia Research Foundation |
United States,
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
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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