Assessing the Efficacy of Intravenous Acetaminophen Versus the Oral Formulation for Perioperative Pain Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 174

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

174 adult patients from the orthopedic surgeons undergoing total knee replacement with spinal anesthesia will be enrolled. Patients will be enrolled for the study the morning of their surgery. Subjects will randomly receive one of the three treatments. The study will be double blind, randomized; placebo controlled comparing PO and IV acetaminophen to each other and a control (placebo). At the time patients arrive in the 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores assessed and recorded by using the numeric rating scale	The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale, from 1-10, every 15 minutes.	Participants will be followed for the duration of their inpatient hosptial stay, an expected average of one week.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to rescue analgesia	The amount of time after the surgery is completed until a patient receives rescue analgesia will be measured in minutes.	Participants will be followed for the duration of their hospital stay, an expected average of one week
Time to post-anesthesia care unit (PACU) discharge	The time from arrive in the PACU to discharge will be measured in minutes.	Participants will be followed for the duration of their PACU stay, an expected average of 5 hours.
Opioid Use	The investigators will collect total amount of oral and/ or intravenous hydromorphone that is consumed by for adequate analgesia.	Participants will be followed for six hours postoperatively.
Postoperative nausea and vomiting	The investigators will collect information on postoperative nausea and vomiting.	Participants will be followed for six hours postoperatively.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Jingping Wang, MD, Ph.D., Massachusetts General Hospital

Publications and helpful links

General Publications

• O'Neal JB, Freiberg AA, Yelle MD, Jiang Y, Zhang C, Gu Y, Kong X, Jian W, O'Neal WT, Wang J. Intravenous vs Oral Acetaminophen as an Adjunct to Multimodal Analgesia After Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind Clinical Trial. J Arthroplasty. 2017 Oct;32(10):3029-3033. doi: 10.1016/j.arth.2017.05.019. Epub 2017 May 18.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: August 11, 2014
• First Submitted That Met QC Criteria: August 12, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: August 12, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Total knee replacement; Acetaminophen; Numeric rating scale
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2014P001139