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



Status:Completed
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 89
Updated:10/15/2017
Start Date:November 2013
End Date:July 2015

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

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.

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.

Inclusion Criteria:

- Is scheduled for knee arthroscopy with or without chondroplasty.

- Scheduled arthroscopy procedure will not include ligament repairs or ligament
reconstructions and/or bone cutting or fixation procedures.

- Has not received any acetaminophen (IV, PR, PO) within at least 8 hours of the
initiation of surgery.

- Is willing and able to sign an informed consent.

Exclusion Criteria:

- Is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or
fixation procedures

- Has self-reported and/or documented previous hypersensitivity to acetaminophen.

- Has self-reported and/or documented history of hepatic disease or impairment.

- Pre-operative calculated creatinine clearance (CrCL) less than 40 ml/min.

- Has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic
beverages per day.

- Has a medical history of substance dependence (i.e. prescription analgesics or illegal
drugs such as cocaine, heroin, etc…). May be self-reported or maybe per the judgment
of the physician PI/Sub-I.
We found this trial at
1
site
400
Celebration, Florida 34747
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Celebration, FL
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