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
Overview
- Phase
- Phase 4
- Intervention
- Oral acetaminophen
- Conditions
- Post-op Pain
- Sponsor
- Kettering Health Network
- Enrollment
- 515
- Locations
- 1
- Primary Endpoint
- Total Post-operative Use of Opioids
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
Subjects will be randomized to receive perioperative dosing of either: 1. Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR, 2. 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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
Oral acetaminophen
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.
Intervention: Oral acetaminophen
IV acetaminophen
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.
Intervention: IV acetaminophen
Outcomes
Primary Outcomes
Total Post-operative Use of Opioids
Time Frame: During post-op period up to 24 hrs after surgery
Post-operative use of opioids, measured in morphine milligram equivalent (MME) units
Secondary Outcomes
- Patient-rated Pain in the Post-operative Period(Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery)