Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-25 @ 6:51 PM
Study NCT ID:
NCT02025634
Status:
COMPLETED
Last Update Posted:
2020-10-26
First Post:
2013-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy
Sponsor:
AdventHealth
Organization:
Study Overview
Official Title:
Determining the Efficacy of Intravenous Acetaminophen as a Non-Narcotic Postoperative Pain Management Technique Following Knee Arthroscopy
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IVTYLENOL
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: