Femoro Acetabular Impingement
Conditions
Keywords
hip arthroscopy
Brief summary
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
Detailed description
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.
Interventions
local field infiltration
PROCEDUREFascia iliaca blockade
fascia iliaca compartment blockade
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients (\>18 years old) * diagnosed FAI that are indicated for hip arthroscopic labral repair and femoroplasty/acetabuloplasty.
Exclusion criteria
* patients undergoing revision procedures, bilateral procedures, * advanced osteoarthritis (\<2mm joint space on plain radiographs) * frank dysplasia (anterior and/or lateral center edge angles \<20 degrees and/or Tonnis angle \>15 degrees) * diagnoses other than FAI (Legg Calve Perthes, femoral head avascular necrosis, septic arthritis, or post traumatic deformity). * allergy to liposomal bupivicaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | post op days 1-4 (Average VAS score of first 4 days of post op) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Utilization | total pill taken over the course of days 1-4 post op. | 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 Number of at Home Falls. | Post op days 1-7 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivicaine Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control
liposomal bupivicaine: local field infiltration | 20 |
| 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 | 17 |
| Total | 37 |
Baseline characteristics
| Characteristic | Liposomal Bupivicaine | Fascia Iliaca Blockade | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 17 Participants | 37 Participants |
| BMI | 26.4 Kg/m^2 | 25.7 Kg/m^2 | 26.05 Kg/m^2 |
| pre-op Visual analogue scale score | 3.2 CM | 2.2 CM | 2.7 CM |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 20 participants | 17 participants | 37 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
| Traction time | 36.0 MINUTES | 36.8 MINUTES | 36.4 MINUTES |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 17 |
| other Total, other adverse events | 0 / 20 | 6 / 17 |
| serious Total, serious adverse events | 0 / 20 | 0 / 17 |
Outcome results
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.
Time frame: post op days 1-4 (Average VAS score of first 4 days of post op)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Liposomal Bupivicaine | Visual Analogue Scale | 2.4 cm |
| Fascia Iliaca Blockade | Visual Analogue Scale | 2.7 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.
Time frame: total pill taken over the course of days 1-4 post op.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Liposomal Bupivicaine | Narcotic Utilization | 7.6 number of pills |
| Fascia Iliaca Blockade | Narcotic Utilization | 7.8 number of pills |
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.
Time frame: Post op days 1-7
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivicaine | Total Number of at Home Falls. | 0 total number of falls |
| Fascia Iliaca Blockade | Total Number of at Home Falls. | 6 total number of falls |