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The purpose of this study is to compare the effectiveness of fascia iliaca blockade vs local field infiltration with liposomal bupivicaine in controlling pain, narcotic utilization and falls in the postoperative period following hip arthroscopy
The purpose the research is to help determine optimal means of post-operative analgesia following hip arthroscopic procedures. Post-operative pain is a significant contributor to patient satisfaction and the side effects of narcotic pain medication are well described. The ideal intervention for achieving appropriate analgesia following hip arthroscopy has not yet been defined. Determining means of achieving acceptable post-operative pain relief while minimizing narcotic usage will help yield maximal patient outcomes.The primary research procedures entailed in this study include fascia iliaca nerve blockade with Marcaine and local field infiltration with liposomal bupivicane (Exparel). The patients in this study will include those who have both a clinical and radiographic diagnosis of femoracetabular impingement (FAI), have failed non operative treatment, and are indicated for hip arthroscopy with labral repair and femoroplasty/acetabuloplasty. The study includes the surgical procedure and the first post-operative follow up visit. The total study duration is approximately 1.5 weeks for each patient. The study will be carried out until the patients first post-operative visit which typically occurs 7-10 days after the procedure. We are to include approximately 40 patients in total for this study over a period of 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivicaine | Active Comparator | Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control |
|
| fascia iliaca blockade | Active Comparator | Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal bupivicaine | Drug | local field infiltration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | pain scale Questionnaire 0 equals no pain at all and 10 equals the worst. The out come measure time frame is reported as the average VAS score of the first 4 day post op. | post op days 1-4 (Average VAS score of first 4 days of post op) |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Utilization | Record of number of narcotic pain pills utilized by patients . This was reported as a total from post op day 1 to 4. The number listed is an average from each patient, from the total pills taken at home. | total pill taken over the course of days 1-4 post op. |
| Total Number of at Home Falls. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Banffy, MD | Cedars Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerlan Jobe | Los Angeles | California | 90045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28802777 | Background | Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25. | |
| 24061718 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivicaine | Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration |
| FG001 | Fascia Iliaca Blockade | Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivicaine | Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration |
| BG001 | Fascia Iliaca Blockade |
| 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 Analogue Scale | pain scale Questionnaire 0 equals no pain at all and 10 equals the worst. The out come measure time frame is reported as the average VAS score of the first 4 day post op. | Posted | Mean | Full Range | cm | post op days 1-4 (Average VAS score of first 4 days of post op) |
|
The adverse events occurred through post op days 1-7 for each patient.
An adverse event is defined as a fall post op.
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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 | Liposomal Bupivicaine | Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
We did not meet target enrollment due to safety concerns.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Banffy | Cedar Sinai -Kerlan Jobe | (310) 665-7200 | Michael.Banffy@cskerlanjobe.org |
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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 | Dec 27, 2018 | Apr 14, 2021 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D057925 | Femoracetabular Impingement |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Fascia iliaca blockade | Procedure | fascia iliaca compartment blockade |
|
number of falls occurring at home after discharge. This is the total number of falls of all patients in each group, over the first 7 days post op. This is not reported as a mean. |
| Post op days 1-7 |
| Krych AJ, Baran S, Kuzma SA, Smith HM, Johnson RL, Levy BA. Utility of multimodal analgesia with fascia iliaca blockade for acute pain management following hip arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):843-7. doi: 10.1007/s00167-013-2665-y. Epub 2013 Sep 24. |
Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control
Fascia iliaca blockade: fascia iliaca compartment blockade
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| BMI | BMI utilized for each hip scope .It is a demographic characteristic not a result of the research medication that was being tested . As such, this as not analyzed and standard deviation is not necessary. | Mean | Full Range | Kg/m^2 |
|
| Traction time | Traction time s utilized for each hip scope .It is a demographic characteristic not a result of the research medication that was being tested . As such, this as not analyzed and standard deviation is not necessary. | Mean | Full Range | MINUTES |
|
| pre-op Visual analogue scale score | Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. 0 equals no pain and 10 represents the worst pain. | Mean | Full Range | CM |
|
|
|
| Secondary | Narcotic Utilization | Record of number of narcotic pain pills utilized by patients . This was reported as a total from post op day 1 to 4. The number listed is an average from each patient, from the total pills taken at home. | Posted | Mean | Full Range | number of pills | total pill taken over the course of days 1-4 post op. |
|
|
|
| Secondary | Total Number of at Home Falls. | number of falls occurring at home after discharge. This is the total number of falls of all patients in each group, over the first 7 days post op. This is not reported as a mean. | Posted | Number | total number of falls | Post op days 1-7 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Fascia Iliaca Blockade | Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade | 0 | 17 | 0 | 17 | 6 | 17 |
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