NCT02025634

Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy

Determining the Efficacy of Intravenous Acetaminophen as a Non-Narcotic Postoperative Pain Management Technique Following Knee Arthroscopy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized, placebo controlled, single blind study is to determine if postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. Particular focus will be on the postoperative opioid consumption. In addition, we will ascertain if the total time the participant is in the PACU differs in those who receive the IV acetaminophen versus those who do not.

Detailed description

This is a randomized, placebo controlled, single blind study of intravenous (IV) acetaminophen in a postoperative arthroscopy patient population. Although use of this medication as a non-narcotic analgesia has been validated in other patient populations such as post operative pelvic and abdominal surgeries, it has not been demonstrated in those who have recently undergone knee arthroscopy with or without chondroplasty. In this study all participants will be injected with a standard of care intra-articular dose of ropivacaine HCl, .2% (Naropin) prior to transfer to the Post Anesthesia Care Unit (PACU). Each will be randomized 1:1 to receive IV acetaminophen in 100ml of 0.9% NS (treatment group) or a 100 ml 0.9 % NS placebo (control). The PACU nursing staff will periodically ascertain the participants' pain scores on a 0-10 scale. All other pain medication or related treatment will be recorded. Statistical analysis will be done to determine if there is a difference in pain scores between the treatment versus control group. Further evaluation will examine if opioid consumption and total time in PACU differs between groups.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Intravenous Acetaminophen	Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.
DRUG	Placebo (0.9% Normal Saline infusion)	Infusion of 100 ml of 0.9% NS

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-01-01
• Last updated: 2020-10-26
• Results posted: 2020-10-26

Locations

1 site across 1 country: United States