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This study will be a prospective, single-blinded, randomized controlled trial (RCT), investigating the influence of the number of opioid pills prescribed following primary hip arthroscopy. All patients who sign the consent form will be enrolled in the suited and randomized to one of the two treatment arms. The intervention group will receive 5 Norco pills, gabapentin (30 mg, once daily for 10 days following surgery), and Tylenol (1000 mg, three times daily for 10 days following surgery) while the control will receive the standard at our practice of 30 Norco pills.
Follow-up will take place at 1, 3, 6, and 12 months postoperatively. Variables of interest will include postoperative patient pain scores (i.e. Visual Analog Scale or VAS), total morphine equivalents taken in the first 30 days after discharge, number of unused opioid pills, opioid disposal rates, and standard patient reported outcomes measures (PROMs) including hip disability and osteoarthritis outcome score (HOOS), Harris Hip score (HHS), VAS for pain, international hip outcome tool (iHOT-12), and Hip outcome score (HOS).
For the purpose of this study, the investigators propose two standardized prescribing patterns across all teams. The first would be the control postoperative prescribing pattern and the second would be the experimental opioid reduced prescribing pattern. Patients will not be informed if their postoperative prescriptions are part of the control or opioid reduced prescribing pattern. Of note, patients will be allowed to cross over from the opioid reduced experimental group to the standard of care control group if they have breakthrough pain following surgery.
Timeline of Events:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Control Group will receive the following pain medication regimen: - Norco (hydrocodone-acetaminophen) 5mg-325mg, 30 total pills The following non-opioid medications are standard of care at our practice following hip arthroscopy and, thus, will be prescribed to patients regardless of the group they are randomized to: aspirin (325 mg, two times daily for 30 days) and Indocin (75 mg extended release, one time daily for 10 days). |
|
| Experimental Group - Opioid Reduced | Experimental | Experimental - opioid reduced: 50% less oxycodone relative to control group
The following non-opioid medications are standard of care at our practice following hip arthroscopy and, thus, will be prescribed to patients regardless of the group they are randomized to: aspirin (325 mg, two times daily for 30 days) and Indocin (75 mg extended release, one time daily for 10 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Group Regimen | Other | Norco (hydrocodone-acetaminophen) 5mg-325mg, 30 total pills. This is the standard of care prescribing procedure for pain management after hip arthroscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | 1 month postoperatively |
| Pain Score | Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | 3 months postoperatively |
| Pain Score | Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | 6 months postoperatively |
| Pain Score | Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | 12 months postoperatively |
| Total morphine equivalents taken | Standardized reporting of amount of opioids taken | In the first 30 days after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Hip disability and osteoarthritis outcome score | assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. The outcome score consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL). Pain (P) includes 10 items with a total score of 40 points, Symptoms (S) includes 5 items with a total score of 20, Activity limitations daily living (ADL) includes 17 items with a total score of 68 and finally Function in sport and recreation (SP) and hip related quality of life both include 4 items with a total score of 16 each. The outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carla M. Edwards | Contact | 312-563-5735 | carla_edwards@rush.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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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 | Apr 30, 2021 | Jul 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D057925 | Femoracetabular Impingement |
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
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Investigators propose two standardized prescribing patterns across all teams. The first would be the control postoperative prescribing pattern and the second would be the experimental opioid reduced prescribing pattern. Patients will not be informed if their postoperative prescriptions are part of the control or opioid reduced prescribing pattern. Of note, patients will be allowed to cross over from the opioid reduced experimental group to the standard of care control group if they have breakthrough pain following surgery.
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| Opioid reduced regimen | Other | Tylenol extra strength (1000 mg, three times daily for 10 days following surgery), Gabapentin (300 mg at night for 10 days following surgery) and Norco (hydrocodone-acetaminophen) 5mg-325mg, 5 total pills |
|
| Number of unused opioid pills |
Pills not taken by patient |
| In the first 30 days after discharge |
| Opioid disposal rates | Number of unused pills properly disposed of | In the first 30 days after discharge |
| 1 month postoperatively |
| Hip disability and osteoarthritis outcome score | assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. The outcome score consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL). Pain (P) includes 10 items with a total score of 40 points, Symptoms (S) includes 5 items with a total score of 20, Activity limitations daily living (ADL) includes 17 items with a total score of 68 and finally Function in sport and recreation (SP) and hip related quality of life both include 4 items with a total score of 16 each. The outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. | 3 months postoperatively |
| Hip disability and osteoarthritis outcome score | assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. The outcome score consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL). Pain (P) includes 10 items with a total score of 40 points, Symptoms (S) includes 5 items with a total score of 20, Activity limitations daily living (ADL) includes 17 items with a total score of 68 and finally Function in sport and recreation (SP) and hip related quality of life both include 4 items with a total score of 16 each. The outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. | 6 months postoperatively |
| Hip disability and osteoarthritis outcome score | assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. The outcome score consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL). Pain (P) includes 10 items with a total score of 40 points, Symptoms (S) includes 5 items with a total score of 20, Activity limitations daily living (ADL) includes 17 items with a total score of 68 and finally Function in sport and recreation (SP) and hip related quality of life both include 4 items with a total score of 16 each. The outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. | 12 months postoperatively |
| Harris Hip score | gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction. | 1 month postoperatively |
| Harris Hip score | gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction. | 3 months postoperatively |
| Harris Hip score | gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction. | 6 months postoperatively |
| Harris Hip score | gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction. | 12 months postoperatively |
| International hip outcome tool | comprised of 33 questions. Patients are asked to place a mark on a Visual Analog Scale (VAS) line for each question, with "significantly impaired" on the far left and "no problems at all" on the far right. total score is then calculated as the mean of all VAS scores as measured in millimeters. | 1 month postoperatively |
| International hip outcome tool | comprised of 33 questions. Patients are asked to place a mark on a Visual Analog Scale (VAS) line for each question, with "significantly impaired" on the far left and "no problems at all" on the far right. total score is then calculated as the mean of all VAS scores as measured in millimeters. | 3 months postoperatively |
| International hip outcome tool | comprised of 33 questions. Patients are asked to place a mark on a Visual Analog Scale (VAS) line for each question, with "significantly impaired" on the far left and "no problems at all" on the far right. total score is then calculated as the mean of all VAS scores as measured in millimeters. | 6 months postoperatively |
| International hip outcome tool | comprised of 33 questions. Patients are asked to place a mark on a Visual Analog Scale (VAS) line for each question, with "significantly impaired" on the far left and "no problems at all" on the far right. total score is then calculated as the mean of all VAS scores as measured in millimeters. | 12 months postoperatively |
| Hip outcome score | questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items. Both subscales are marked separately and 17 items from the Activities of daily living scale are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. 'Not applicable' responses are also possible options. The total score is then multiplied by 4 to get the highest potential score which can be no greater than 68. An overall higher score from both of these sub-scales represents a greater level of function. | 1 month postoperatively |
| Hip outcome score | questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items. Both subscales are marked separately and 17 items from the Activities of daily living scale are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. 'Not applicable' responses are also possible options. The total score is then multiplied by 4 to get the highest potential score which can be no greater than 68. An overall higher score from both of these sub-scales represents a greater level of function. | 3 months postoperatively |
| Hip outcome score | questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items. Both subscales are marked separately and 17 items from the Activities of daily living scale are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. 'Not applicable' responses are also possible options. The total score is then multiplied by 4 to get the highest potential score which can be no greater than 68. An overall higher score from both of these sub-scales represents a greater level of function. | 6 months postoperatively |
| Hip outcome score | questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items. Both subscales are marked separately and 17 items from the Activities of daily living scale are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. 'Not applicable' responses are also possible options. The total score is then multiplied by 4 to get the highest potential score which can be no greater than 68. An overall higher score from both of these sub-scales represents a greater level of function. | 12 months postoperatively |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |