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determined not to be feasible at our site
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The purpose of this research is to determine differences in outcomes in patients who receive regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement.
Methods: After informed consent is obtained at a routine/pre-surgical clinic visit, all patients who meet eligibility criteria will undergo randomization into one of two groups. These groups are 1) to receive regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy, or 2) undergo a subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water) instead of bupivacaine. Intra-operatively, both groups will receive general anesthesia and local anesthesia (lidocaine and bupivacaine in the peripheral compartment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| regional anesthesia bupivacaine | Active Comparator | regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy |
|
| regional anesthesia placebo | Placebo Comparator | subcutaneous injection procedure placebo (0.9% sodium chloride in water) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| regional anesthesia bupivacaine | Drug | a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject log to record number of pain pills taken by subject for 7 days | A log that is used by the subject to record how many oral pain medications they take for 7 days. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Record of Pain Medication given in PACU | Record narcotic requirements in PACU | immediately post-op (while in PACU, on average 1-4 hours total) |
| Harris Hip score | Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ajay Aggarwal, MD | University of Missouri Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Health System | Columbia | Missouri | 65212 | United States |
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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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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| regional anesthesia placebo | Drug | subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water) |
|
|
| 6 weeks |
| Visual analog pain scale | Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits. | 6 weeks |
| iHOT-12 (international hip outcome tool) | Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits. | 6 weeks |
| HOOS (hip disability and osteoarthritis outcome score) | Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits. | 6 weeks |
| Duration of time in PACU | immediately post-op, on average between 1-4 hours |
| Reported Falls Post-op | Time inpatient, on average 12-48 hours |
| Unplanned admissions and/or readmissions | number of unplanned admissions/readmission | 6 weeks |
| Days until starting rehabilitation | immediately post-op, on average 24 hours - 2 weeks |
| Patient satisfaction | 6 weeks |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |