Pain, PostoperativePhase 4IVTYLENOLNCT02025634
Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy
A Phase 4 study testing Intravenous Acetaminophen in people with Pain, Postoperative, run by AdventHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Intravenous Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jul 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Hospital Celebration Health
Celebration, Florida, 34747
About this study
Official title: 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.
Read the 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
- Being tested
- Intravenous Acetaminophen, Placebo (0.9% Normal Saline infusion)
- Keywords
- Pain, Postoperative, Ofirmev, Acetaminophen, Analgesics, Non-Narcotic, Arthroscopy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous AcetaminophenDrug
Also called Ofirmev
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)Drug
Also called NS
Infusion of 100 ml of 0.9% NS
| Study group | Role | What they receive |
|---|---|---|
| Intravenous acetaminophen | Experimental | Infusion of Intravenous acetaminophen (Ofirmev) Receives: Drug: Intravenous Acetaminophen |
| Placebo (0.9% Normal Saline Infusion) | Placebo comparator | Infusion of 100 ml of 0.9 NS Normal Saline Receives: Drug: Placebo (0.9% Normal Saline infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Levels
To determine if postoperative pain levels, as measured by a Verbal Numerical Rating Scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. In the VNRS, the user has the option to verbally rate their scale from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible.
Measured: up to 8 hours
Secondary outcomes (1)
Postoperative Opioid Consumption
To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively.
Measured: up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- University of Central Florida
- Responsible party
- Sponsor
- Investigators
- Bradley Homan, DO, Principal investigator, Florida Hospital Celebration Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025634
- Sponsor's protocol ID
- 503526
- Acronym
- IVTYLENOL
- Status last verified
- Oct 2020
- First submitted
- 30 Dec 2013
- Last updated
- 26 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Efficacy of Intravenous Acetaminophen as a Non-Narcotic Postoperative Pain Management Technique Following Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT02025634
- Acronym / sponsor ID
- IVTYLENOL / 503526
- Conditions
- Pain, Postoperative
- Keywords
- Pain, Postoperative, Ofirmev, Acetaminophen, Analgesics, Non-Narcotic, Arthroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- University of Central Florida
- Study start
- Nov 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Posted 26 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous acetaminophen | Experimental | Drug: Intravenous AcetaminophenInfusion of Intravenous acetaminophen (Ofirmev) |
| Placebo (0.9% Normal Saline Infusion) | Placebo comparator | Drug: Placebo (0.9% Normal Saline infusion)Infusion of 100 ml of 0.9 NS Normal Saline |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous AcetaminophenAlso: OfirmevParticipants 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 | Intravenous acetaminophen |
| Placebo (0.9% Normal Saline infusion)Also: NSInfusion of 100 ml of 0.9% NS | Drug | Placebo (0.9% Normal Saline Infusion) |
Primary outcome
Postoperative Pain Levels
Time frame: up to 8 hours
To determine if postoperative pain levels, as measured by a Verbal Numerical Rating Scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. In the VNRS, the user has the option to verbally rate their scale from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible.
1 secondary outcome
Postoperative Opioid Consumption
Time frame: up to 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Homan, DO principal investigator
Florida Hospital Celebration Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Acetaminophen in people with Pain, Postoperative, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Levels (time frame: up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.