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This study is being conducted to evaluate the effectiveness of post-operative pain control without using narcotic pain medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Group | Active Comparator | Subjects will receive standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure |
|
| Non-Opiate Pain Control Group | Experimental | Subjects will receive a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | 5 mg tablets every 4 hours postoperatively as needed for pain control |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score | The change in pain score measured using a visual analog scale (VAS) to rate pain on a scale 0-10; 0=no pain to 10=worst possible pain with higher scores indicating worsening pain. | 1 day post-operatively, 14 days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score | The PROMIS Pain Interference Score is a 6-item patient-reported measure assessing how pain disrupts daily activities. Responses are scored on a 5-point Likert scale (1= Not at all to 5= very much). Each item is scored individually, and the raw scores are summed to produce a total score. The total raw score is then converted to a T-score which standardizes the score with a mean of 50 and a standard deviation of 10 based on the general population. Higher T-scores indicate greater interference. |
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Inclusion Criteria:
• Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelechi Okoroha, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo clinic | Rochester | Minnesota | 55401 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Group | Subjects received standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure Oxycodone: 5 mg tablets every 4 hours postoperatively as needed for pain control |
| FG001 | Non-Opiate Pain Control Group | Subjects received a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure. Ibuprofen: 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day Gabapentin: 300 mg three times a day for 5 days then wean off by day 10 postoperatively Acetaminophen: 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day Methocarbamol: 500 mg three times a week for 2 weeks postoperatively |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Group | Subjects received standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure Oxycodone: 5 mg tablets every 4 hours postoperatively as needed for pain control |
| BG001 | Non-Opiate Pain Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Pain Score | The change in pain score measured using a visual analog scale (VAS) to rate pain on a scale 0-10; 0=no pain to 10=worst possible pain with higher scores indicating worsening pain. | Posted | Mean | Standard Deviation | score on a scale | 1 day post-operatively, 14 days post-operatively |
|
Adverse events were collected from the time of informed consent through study completion, approximately 6 weeks.
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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 | Standard of Care Group | Subjects received standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure Oxycodone: 5 mg tablets every 4 hours postoperatively as needed for pain control |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelechi Okoroha, M.D. | Mayo Clinic | 832-423-9895 | okoroha.kelechi@mayo.edu |
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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 | Sep 6, 2024 | May 6, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D007052 | Ibuprofen |
| D000077206 | Gabapentin |
| D000082 | Acetaminophen |
| D008721 | Methocarbamol |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Ibuprofen | Drug | 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day |
|
| Gabapentin | Drug | 300 mg three times a day for 5 days then wean off by day 10 postoperatively |
|
| Acetaminophen | Drug | 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day |
|
| Methocarbamol | Drug | 500 mg three times a week for 2 weeks postoperatively |
|
|
| Baseline; 14 days post operatively |
| Change in Opioid Consumption | The change in opioid consumption from day 1 post-operative to day 14 post-operative in the opioid arm expressed in morphine milligram equivalents (MME). | Day 1 Post-Operatively; Day 14 Post-Operatively |
Subjects received a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure. Ibuprofen: 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day Gabapentin: 300 mg three times a day for 5 days then wean off by day 10 postoperatively Acetaminophen: 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day Methocarbamol: 500 mg three times a week for 2 weeks postoperatively |
| BG002 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score | The PROMIS Pain Interference Score is a 6-item patient-reported measure assessing how pain disrupts daily activities. Responses are scored on a 5-point Likert scale (1= Not at all to 5= very much). Each item is scored individually, and the raw scores are summed to produce a total score. The total raw score is then converted to a T-score which standardizes the score with a mean of 50 and a standard deviation of 10 based on the general population. Higher T-scores indicate greater interference. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 14 days post operatively |
|
|
|
| Secondary | Change in Opioid Consumption | The change in opioid consumption from day 1 post-operative to day 14 post-operative in the opioid arm expressed in morphine milligram equivalents (MME). | This outcome measure was looking at opioid consumption post-operatively, due to this, this outcome measure only applied to the standard of care arm as the non-opiate pain control group did not consume opioids. | Posted | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | Day 1 Post-Operatively; Day 14 Post-Operatively |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 33 |
| 43 |
| EG001 | Non-Opiate Pain Control Group | Subjects received a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure. Ibuprofen: 800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day Gabapentin: 300 mg three times a day for 5 days then wean off by day 10 postoperatively Acetaminophen: 1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day Methocarbamol: 500 mg three times a week for 2 weeks postoperatively | 0 | 43 | 0 | 43 | 33 | 43 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Light-headed/dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Break-through pain | General disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Upset Stomach | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Blurry Vision | Eye disorders | Non-systematic Assessment |
|
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D003509 | Cyclohexanecarboxylic Acids |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D006140 | Guaifenesin |
| D006139 | Guaiacol |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |