PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement

Study Overview
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Brief Summary
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The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen

Detailed Description
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Subjects will be randomized to receive perioperative dosing of either: Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR, IV acetaminophen (Ofirmev) 1000mg/100ml with Oral Placebo (oral capsules). Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery.

Official Title
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Randomized, Double-Blind, Study Comparing Oral Acetaminophen Plus Intravenous (IV) Placebo to Oral Placebo Plus IV Acetaminophen Given Perioperatively for Controlling Pain in the 24hr Post-op Period After Total Hip or Knee Joint Replacement

Conditions
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Post-op Pain

Intervention / Treatment
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* Drug: Oral acetaminophen
* Drug: IV acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Able to provide written consent Able to read and write in English Weighing over 50 kg Will undergo total hip or total knee joint replacement Exclusion Criteria: Non-verbal patients Unable to use numeric pain scale Allergic to the test article Documented hepatic impairment or failure Current illicit drug use Requires traumatic or emergent surgery Pregnant women Women who are breastfeeding Prisoners Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA) Unable to swallow oral capsules

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral acetaminophen<br>Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. | Drug: Oral acetaminophen<br>* Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.<br>* Other names: Tylenol;|
| Active Comparator: IV acetaminophen<br>Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. | Drug: IV acetaminophen<br>* Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.<br>* Other names: Ofirmev;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Post-operative Use of Opioids | Post-operative use of opioids, measured in morphine milligram equivalent (MME) units | During post-op period up to 24 hrs after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-rated Pain in the Post-operative Period | Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient. | Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip replacement, Knee replacement, randomized trial, acetaminophen, post-op pain management