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| Name | Class |
|---|---|
| University of Central Florida | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous acetaminophen | Experimental | Infusion of Intravenous acetaminophen (Ofirmev) |
|
| Placebo (0.9% Normal Saline Infusion) | Placebo Comparator | Infusion of 100 ml of 0.9 NS Normal Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Acetaminophen | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Opioid Consumption | To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively. | up to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Time in Post Anesthesia Care Unit (PACU) (or "Recovery Room") | To ascertain if the total time the participant remains in the PACU (from admission to discharge) differs between those who received IV acetaminophen versus those who do not receive IV acetaminophen. | up to 8.6 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Homan, DO | Florida Hospital Celebration Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital Celebration Health | Celebration | Florida | 34747 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Acetaminophen | Infusion of Intravenous acetaminophen (Ofirmev) 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. |
| FG001 | Placebo (0.9% Normal Saline Infusion) | Infusion of 100 ml of 0.9 NS Normal Saline Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Acetaminophen | Infusion of Intravenous acetaminophen (Ofirmev) 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | up to 8 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Acetaminophen | Infusion of Intravenous acetaminophen (Ofirmev) 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brad Homan | AdventHealth | 407-303-4270 | Brad.Homan.MD@AdventHealth.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Placebo (0.9% Normal Saline infusion) | Drug | Infusion of 100 ml of 0.9% NS |
|
|
| Placebo (0.9% Normal Saline Infusion) |
Infusion of 100 ml of 0.9 NS Normal Saline Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Infusion of 100 ml of 0.9 NS Normal Saline Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS |
|
|
| Secondary | Postoperative Opioid Consumption | To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively. | Posted | Mean | Full Range | mg | up to 8 hours |
|
|
|
| Other Pre-specified | Total Time in Post Anesthesia Care Unit (PACU) (or "Recovery Room") | To ascertain if the total time the participant remains in the PACU (from admission to discharge) differs between those who received IV acetaminophen versus those who do not receive IV acetaminophen. | Posted | Mean | Full Range | hours | up to 8.6 hours |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Placebo (0.9% Normal Saline Infusion) | Infusion of 100 ml of 0.9 NS Normal Saline Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS | 0 | 54 | 0 | 54 | 0 | 54 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |