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The purpose of the study is to determine if opiates are required to achieve appropriate analgesia after hip arthroscopy in outpatient surgery. The investigators hypothesize that patients are frequently prescribed more opiates than are needed after surgery, resulting in excess medications that are at risk for misuse, diversion and contribution to the opioid epidemic
Perioperative pain management is an important aspect of quality patient care. Opioid pain medications are increasingly being used for pain control, with the United States writing over 250 million prescriptions for painkillers per year. Increased usage has led to unintended negative consequences for individuals and society. It is estimated that 46 people die each day from an overdose of prescription painkillers, and individual use can lead to the development of tolerance and worse treatment outcomes. Further issues arise when opioids are misused, it is estimated that nontherapeutic use has increased three fold in recent years. In the United States alone in 2006 the estimated total cost of opioid prescription misuse was $53.4 billion, of which $42 billion was attributed to lost productivity, $8.2 billion to criminal justice cost and the remainder drug abuse treatment and medical complications. The federal government has recognized this epidemic and raised a call for clinicians to more responsibly prescribe opiate pain medications
Opiate use has increased in recent years, from 2000-2010 the use of opiates in office based visits nearly doubled from 11.3% to 19.6% whereas there was no change in the prescribing of non-opioid pharmacotherapies. Further, when specifically looking at new musculoskeletal pain visits, one half resulted in pharmacologic treatment, with the prescribing of non-opioid pharmacotherapies decreasing from 38% to 29% from 2000 to 2010, respectively. The clinical use of opioids for post-operative pain control has also been linked to the opioid epidemic and risk of future abuse. Legitimate opioid use before high school graduation is independently associated with a 33% increased risk of future misuse after high school.
It has been estimated that orthopedic surgeons prescribe 7.7% of all opioids in the United States.Special attention needs to be paid to the amount of opioid pain medications orthopedic surgeons prescribe to patients after ambulatory surgery, there is considerable variability among surgeon and procedure in regards to the amount of opioids to prescribe with many patients left with excess unused medication .An analysis of 250 patients undergoing outpatient upper extremity surgery found that on average patients consumed 10 opioid pills, with 19 pills left over and a total of 4,639 pills going unused in the cohort. Leftover prescription opioids are at risk for diversion to family and friends for nonmedical use. Further studies are needed to quantify the amount of opioids to prescribe for specific orthopedic procedures to limit excess narcotic use, misuse, diversion and contribution to the opioid epidemic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Hip Arthroscopy | Active Comparator | Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. |
|
| Group 2 - Hip Arthroscopy | Active Comparator | Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 - Opiate Tablets post Hip Arthroscopy | Other | Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) Pain Scores | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient | Baseline (pre-operative) |
| Numeric Pain Rating Scale (NPRS) Pain Scores | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient | 2 hours post-operative |
| Numeric Pain Rating Scale (NPRS) Pain Scores | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient | 24 hours post-operative |
| Numeric Pain Rating Scale (NPRS) Pain Scores | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient | 48 hours post-operative |
| Numeric Pain Rating Scale (NPRS) Pain Scores | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient | 7 days post-operative |
| Opiates Taken | Number of prescribed narcotic pills taken in the preceding time period | 24 hours post-operative |
| Opiates Taken | Number of prescribed narcotic medication tablets taken in the preceding time period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Orthopaedic Surgery | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (60) - Hip Arthroscopy | Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. |
| FG001 | Group 2 (30) - Hip Arthroscopy | Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Hip Arthroscopy | Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. |
| 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 | Numeric Pain Rating Scale (NPRS) Pain Scores | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-operative) |
|
21 days
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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 | Group 1 (60) - Hip Arthroscopy | Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Shauver; Research Project Manager | Northwestern University | 3124726024 | melissa.shauver1@nm.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2019 | Jul 29, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2020 | Jul 29, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D025981 | Hip Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Group 2 - Opiate Tablets post Hip Arthroscopy | Other | Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. |
|
| 48 hours post-operative |
| Opiates Taken | Number of prescribed narcotic medication tablets taken in the preceding time period | 7 days post-operative |
| Opiates Taken | Number of prescribed narcotic medication tablets taken in the preceding time period | 21 days post-operative |
| Opiates Remaining | Number of prescribed narcotic medication tablets remaining from initial amount prescribed | 24 hours post-operative |
| Opiates Remaining | Number of prescribed narcotic medication tablets remaining from initial amount prescribed | 48 hours post-operative |
| Opiates Remaining | Number of prescribed narcotic medication tablets remaining from initial amount prescribed | 7 days post-operative |
| Opiates Remaining | Number of prescribed narcotic medication tablets remaining from initial amount prescribed | 21 days post-operative |
| Date of Last Opiate Taken | Days following surgery that the most recent dose of narcotic medication was taken | 21 days post-operative |
| Numeric Pain Rating Scale (NPRS) Pain Scores | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient | 21 days |
| Number of Participants Reporting Side Effects | As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, itchiness, nausea/vomiting | 24 hours postoperatively |
| Number of Participants Reporting Side Effects | As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting | 48 hours postoperatively |
| Number of Participants Reporting Side Effects | As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting | 7 days postoperatively |
| Number of Participants Reporting Side Effects | As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting | 21 days postoperatively |
| Group 2 - Hip Arthroscopy |
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| Are you an active smoker? | Count of Participants | Participants |
|
| If no, have you ever consistently smoked cigarettes (daily for > 1 month)? | Count of Participants | Participants |
|
| What is your employment status? | Count of Participants | Participants |
|
| Is this injury part of a workers compensation claim? | Count of Participants | Participants |
|
| Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/codone)? | Count of Participants | Participants |
|
| Do you have a personal history of illicit substance abuse? | Count of Participants | Participants |
|
| Do you have a family history of substance abuse (ex. prescription or illicit drugs, alcohol)? | Count of Participants | Participants |
|
| What is the highest level of education you attained? | Count of Participants | Participants |
|
| What is your average yearly household income? | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
|
|
| Primary | Numeric Pain Rating Scale (NPRS) Pain Scores | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient | Posted | Mean | Standard Deviation | score on a scale | 2 hours post-operative |
|
|
|
| Primary | Numeric Pain Rating Scale (NPRS) Pain Scores | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient | Posted | Mean | Standard Deviation | score on a scale | 24 hours post-operative |
|
|
|
| Primary | Numeric Pain Rating Scale (NPRS) Pain Scores | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient | Posted | Mean | Standard Deviation | score on a scale | 48 hours post-operative |
|
|
|
| Primary | Numeric Pain Rating Scale (NPRS) Pain Scores | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient | Posted | Mean | Standard Deviation | score on a scale | 7 days post-operative |
|
|
|
| Primary | Opiates Taken | Number of prescribed narcotic pills taken in the preceding time period | Posted | Mean | Standard Deviation | tablets | 24 hours post-operative |
|
|
|
| Primary | Opiates Taken | Number of prescribed narcotic medication tablets taken in the preceding time period | Posted | Mean | Standard Deviation | tablets | 48 hours post-operative |
|
|
|
| Primary | Opiates Taken | Number of prescribed narcotic medication tablets taken in the preceding time period | Posted | Mean | Standard Deviation | tablets | 7 days post-operative |
|
|
|
| Primary | Opiates Taken | Number of prescribed narcotic medication tablets taken in the preceding time period | Posted | Mean | Standard Deviation | tablets | 21 days post-operative |
|
|
|
| Primary | Opiates Remaining | Number of prescribed narcotic medication tablets remaining from initial amount prescribed | Posted | Mean | Standard Deviation | tablets | 24 hours post-operative |
|
|
|
| Primary | Opiates Remaining | Number of prescribed narcotic medication tablets remaining from initial amount prescribed | Posted | Mean | Standard Deviation | tablets | 48 hours post-operative |
|
|
|
| Primary | Opiates Remaining | Number of prescribed narcotic medication tablets remaining from initial amount prescribed | Posted | Mean | Standard Deviation | tablets | 7 days post-operative |
|
|
|
| Primary | Opiates Remaining | Number of prescribed narcotic medication tablets remaining from initial amount prescribed | Posted | Mean | Standard Deviation | tablets | 21 days post-operative |
|
|
|
| Primary | Date of Last Opiate Taken | Days following surgery that the most recent dose of narcotic medication was taken | Posted | Mean | Standard Deviation | days | 21 days post-operative |
|
|
|
| Primary | Numeric Pain Rating Scale (NPRS) Pain Scores | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient | Posted | Mean | Standard Deviation | score on a scale | 21 days |
|
|
|
| Primary | Number of Participants Reporting Side Effects | As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, itchiness, nausea/vomiting | Posted | Count of Participants | Participants | 24 hours postoperatively |
|
|
|
| Primary | Number of Participants Reporting Side Effects | As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting | Posted | Count of Participants | Participants | 48 hours postoperatively |
|
|
|
| Primary | Number of Participants Reporting Side Effects | As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting | Posted | Count of Participants | Participants | 7 days postoperatively |
|
|
|
| Primary | Number of Participants Reporting Side Effects | As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting | Posted | Count of Participants | Participants | 21 days postoperatively |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Group 2 (30) - Hip Arthroscopy | Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. | 0 | 59 | 0 | 59 | 0 | 59 |
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| Disabled |
|
| Graduate |
|
| $35,000 -$49,999 |
|
| $50,000 -$74,999 |
|
| $75,000 - $99,999 |
|
| $100,000 -$149,999 |
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| $150,000 - $199,999 |
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| $200,000 or more |
|
| missing |
|