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Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FI Block | Experimental | Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine [per 60 mL] and epinephrine 1:400,000) |
|
| Local Injection | Active Comparator | Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivicaine | Drug |
| ||
| clonidine |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Opioid consumption, as measured by narcotic usage (morphine milligram equivalents) | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Time in PACU | Measured time subjects spent in the post anesthesia care unit. | Duration of PACU stay in minutes from end of surgery to discharge from PACA |
| Total Number of Episodes of Nausea and Vomiting |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Kim, MD | Greenville Anesthesiology - Greenville Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steadman Hawkins Clinic of the Carolinas - Greenville Health System | Greenville | South Carolina | 29615 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31999469 | Derived | Glomset JL, Kim E, Tokish JM, Renfro SD, Seckel TB, Adams KJ, Folk J. Reduction of Postoperative Hip Arthroscopy Pain With an Ultrasound-Guided Fascia Iliaca Block: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(3):682-688. doi: 10.1177/0363546519898205. Epub 2020 Jan 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | FI Block | Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine [per 60 mL] and epinephrine 1:400,000) ropivicaine clonidine Epinephrine |
| FG001 | Local Injection | Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Noropin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FI Block | Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine [per 60 mL] and epinephrine 1:400,000) ropivicaine clonidine Epinephrine |
| BG001 | Local Injection |
| 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 | Visual Analog Scale | Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 Months |
|
Patients were assessed throughout their study participation, from surgery through the 3 month follow up.
Both treatment are standard of care.
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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 | FI Block | Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine [per 60 mL] and epinephrine 1:400,000) ropivicaine clonidine Epinephrine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital readmission | General disorders | Systematic Assessment | 2 patients were readmitted for postoperative pain control. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hawkins Foundation Research Coordinator | Hawkins Foundation | 864 454 7458 | info@hawkinsfoundation.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 | Jan 29, 2015 | Oct 31, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| D057925 | Femoracetabular Impingement |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Epinephrine | Drug |
|
| Noropin | Drug |
|
Occurrences of periods of nausea and vomiting
| From end of surgery to discharge from PACU |
| Hospital Readmission | Number of participants that were readmitted to the hospital | 3 months |
Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Noropin |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Opioid Consumption | Opioid consumption, as measured by narcotic usage (morphine milligram equivalents) | Posted | Mean | 95% Confidence Interval | morphine milligram equivalents | 3 Months |
|
|
|
| Other Pre-specified | Time in PACU | Measured time subjects spent in the post anesthesia care unit. | Posted | Mean | 95% Confidence Interval | Minutes | Duration of PACU stay in minutes from end of surgery to discharge from PACA |
|
|
|
| Other Pre-specified | Total Number of Episodes of Nausea and Vomiting | Occurrences of periods of nausea and vomiting | Posted | Number | Number of episodes | From end of surgery to discharge from PACU |
|
|
|
| Other Pre-specified | Hospital Readmission | Number of participants that were readmitted to the hospital | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 1 |
| 41 |
| EG001 | Local Injection | Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Noropin | 0 | 43 | 0 | 43 | 1 | 43 |
|
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| D025981 |
| Hip Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |