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

NCT ID: NCT02025634

Last Updated: 2020-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-07-31

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intravenous acetaminophen

Infusion of Intravenous acetaminophen (Ofirmev)

Group Type: EXPERIMENTAL

Intravenous Acetaminophen

Intervention Type: DRUG

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.

Placebo (0.9% Normal Saline Infusion)

Infusion of 100 ml of 0.9 NS Normal Saline

Group Type: PLACEBO_COMPARATOR

Placebo (0.9% Normal Saline infusion)

Intervention Type: DRUG

Infusion of 100 ml of 0.9% NS

Interventions

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.

Intervention Type: DRUG

Placebo (0.9% Normal Saline infusion)

Infusion of 100 ml of 0.9% NS

Intervention Type: DRUG

Other Intervention Names

Ofirmev; NS

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Central Florida

OTHER

Sponsor Role: collaborator

AdventHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradley Homan, DO

Role: PRINCIPAL_INVESTIGATOR

Florida Hospital Celebration Health

Locations

Florida Hospital Celebration Health

Celebration, Florida, United States

Countries

United States

Other Identifiers

503526

Identifier Type: -

Identifier Source: org_study_id