Assessing the Efficacy of Intravenous Acetaminophen Versus the Oral Formulation for Perioperative Pain Treatment
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | August 2014 |
| End Date: | October 2015 |
| Contact: | Jingping Wang, MD, Ph.D. |
| Email: | jwang23@partners.org |
| Phone: | 6176432729 |
To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and
consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement
with spinal anesthesia.
Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid
consumption, a lower percentage of patients rescuing, or a longer time to first rescue with
IV acetaminophen. The investigators will compare the efficacies of oral and intravenous
acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.
consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement
with spinal anesthesia.
Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid
consumption, a lower percentage of patients rescuing, or a longer time to first rescue with
IV acetaminophen. The investigators will compare the efficacies of oral and intravenous
acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.
Intravenous acetaminophen has rapid onset and potent analgesic properties. Recent studies
have shown several advantages of using intravenous acetaminophen perioperatively. However,
due to its relatively high cost and limited clinical data concerning its efficacy compared
with other agents, physicians are hesitant to use intravenous acetaminophen in the
perioperative period.
174 adult patients from the orthopedic surgeons undergoing total knee replacement with
spinal anesthesia will be enrolled. The study will be double blind, randomized; placebo
controlled comparing oral and IV acetaminophen to each other and a control (placebo). At the
time patients arrive in the post-anesthesia care unit (PACU), Group 1 will receive IV 1 gram
acetaminophen, and PO placebo; Group 2 will receive PO 1 gram acetaminophen and IV placebo;
Group 3 will receive IV placebo and PO placebo.
The primary outcome that will be assessed is pain scores, which will be recorded by using
the numeric rating scale 1-10 every 15 minutes. Secondary outcomes include time to rescue
analgesia (measured in minutes), time to PACU discharge (measured in minutes), and the total
amount of hydromorphone (PO or IV) consumed within 6 hours postoperatively for adequate
analgesia (total measured in milligrams) will be collected.
The difference in pain scores will be assessed by a chi-square test. A multivariable
regression model will be performed with the clinical and statistically significant variables
to remove confounding.
have shown several advantages of using intravenous acetaminophen perioperatively. However,
due to its relatively high cost and limited clinical data concerning its efficacy compared
with other agents, physicians are hesitant to use intravenous acetaminophen in the
perioperative period.
174 adult patients from the orthopedic surgeons undergoing total knee replacement with
spinal anesthesia will be enrolled. The study will be double blind, randomized; placebo
controlled comparing oral and IV acetaminophen to each other and a control (placebo). At the
time patients arrive in the post-anesthesia care unit (PACU), Group 1 will receive IV 1 gram
acetaminophen, and PO placebo; Group 2 will receive PO 1 gram acetaminophen and IV placebo;
Group 3 will receive IV placebo and PO placebo.
The primary outcome that will be assessed is pain scores, which will be recorded by using
the numeric rating scale 1-10 every 15 minutes. Secondary outcomes include time to rescue
analgesia (measured in minutes), time to PACU discharge (measured in minutes), and the total
amount of hydromorphone (PO or IV) consumed within 6 hours postoperatively for adequate
analgesia (total measured in milligrams) will be collected.
The difference in pain scores will be assessed by a chi-square test. A multivariable
regression model will be performed with the clinical and statistically significant variables
to remove confounding.
Inclusion Criteria:
- Patients undergoing total knee replacement
- Successful spinal placement
- ≥18 years old
Exclusion Criteria:
- Failed spinal anesthesia
- Chronic opiate users
- Liver disease patients
- Allergy/hypersensitivity to acetaminophen
- Patients with baseline dementia
- Patients weighing less than 50kg, history of alcohol dependence, renal impairment,
opiate allergy, and pregnancy.
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