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This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of anterior cruciate ligament reconstruction: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen
Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring anterior cruciate ligament reconstruction will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.
Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia
Primary endpoints is reduction in pain as measured by Visual Analogue Scale and Patient-Reported Outcomes Measurement Information System. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.
Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-Operative Non Opioid Pain Protocol | Experimental | Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam |
|
| Post-Operative Traditional Pain Protocol | Active Comparator | Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Post-Operative Non Opioid Pain Protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Levels Using the Visual Analog Scale | Patients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale is a validated measure for pain where 0 is no pain and 10 is the worst pain. Average daily pain was calculated for each patient. Higher values portend worse control. | 10 days post-operatively |
| Patient-Reported Outcomes Measurement Information System | Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) scores will be collected once preoperatively and at 10 days postoperatively. The PROMIS PF is scored on a 0-point to 100-point scale, with a population mean of 50 and SD of 10. 0 is equivalent to no physical function and 100 is equivalent to total physical function. | From preoperative visit to 10 days post-operatively |
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Eligibility Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toufic R Jildeh, MD | Resident | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
Per Request
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| ID | Title | Description |
|---|---|---|
| FG000 | Post-Operative Non Opioid Pain Protocol | Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam Celecoxib: Post-Operative Non Opioid Pain Protocol Ketorolac: Post-Operative Non Opioid Pain Protocol Gabapentin: Post-Operative Non Opioid Pain Protocol Acetaminophen: Post-Operative Non Opioid Pain Protocol Diazepam: Post-Operative Non Opioid Pain Protocol |
| FG001 | Post-Operative Traditional Pain Protocol | Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Post-Operative Non Opioid Pain Protocol | Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam Celecoxib: Post-Operative Non Opioid Pain Protocol Ketorolac: Post-Operative Non Opioid Pain Protocol Gabapentin: Post-Operative Non Opioid Pain Protocol Acetaminophen: Post-Operative Non Opioid Pain Protocol Diazepam: Post-Operative Non Opioid Pain Protocol |
| 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 | Pain Levels Using the Visual Analog Scale | Patients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale is a validated measure for pain where 0 is no pain and 10 is the worst pain. Average daily pain was calculated for each patient. Higher values portend worse control. | Posted | Mean | 95% Confidence Interval | score on a scale (0-10 on VAS pain scale | 10 days post-operatively |
|
10 days postop
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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 | Post-Operative Non Opioid Pain Protocol | Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam Celecoxib: Post-Operative Non Opioid Pain Protocol Ketorolac: Post-Operative Non Opioid Pain Protocol Gabapentin: Post-Operative Non Opioid Pain Protocol Acetaminophen: Post-Operative Non Opioid Pain Protocol Diazepam: Post-Operative Non Opioid Pain Protocol |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
Patients were aware of the medicines they were taking, and knowledge of the treatment may have led to cognitive bias; however, data were recorded by a blinded observer with no knowledge of patient randomization in order to eliminate associated statistical bias.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Toufic Jildeh | Henry Ford Health System | 15172308511 | touficjildeh@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2022 | Mar 4, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| C514822 | oxycodone-acetaminophen |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D000077206 | Gabapentin |
| D000082 | Acetaminophen |
| D003975 | Diazepam |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Hydrocodone-Acetaminophen | Drug | Traditionally used narcotic pain protocol |
|
|
| Ketorolac | Drug | Post-Operative Non Opioid Pain Protocol |
|
|
| Gabapentin | Drug | Post-Operative Non Opioid Pain Protocol |
|
|
| Acetaminophen | Drug | Post-Operative Non Opioid Pain Protocol |
|
|
| Diazepam | Drug | Post-Operative Non Opioid Pain Protocol |
|
|
| BG001 | Post-Operative Traditional Pain Protocol | Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Post-Operative Traditional Pain Protocol | Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol |
|
|
|
| Primary | Patient-Reported Outcomes Measurement Information System | Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) scores will be collected once preoperatively and at 10 days postoperatively. The PROMIS PF is scored on a 0-point to 100-point scale, with a population mean of 50 and SD of 10. 0 is equivalent to no physical function and 100 is equivalent to total physical function. | Posted | Mean | Standard Deviation | score on a scale | From preoperative visit to 10 days post-operatively |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 18 |
| 34 |
| EG001 | Post-Operative Traditional Pain Protocol | Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol | 0 | 28 | 0 | 28 | 13 | 28 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Upset Stomach | Gastrointestinal disorders | Systematic Assessment |
|
| Drowsy | Gastrointestinal disorders | Systematic Assessment |
|
| Loopy | Nervous system disorders | Systematic Assessment |
|
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |