Regional Anesthesia in Hip Arthroscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Use of Regional Anesthesia in Hip Arthroscopy

Conditions
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Femoroacetabular Impingement

Intervention / Treatment
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* Drug: regional anesthesia bupivacaine
* Drug: regional anesthesia placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient undergoing primary hip arthroscopy with labral repair and osteoplasty for hip impingement Age 18-45 years old Not pregnant No history of neuropathic pain No radiographic signs of osteoarthritis of the operative hip (Tönnisgrade 1) Willing and able to comply with post-operative hip arthroscopy protocol No documented allergy to anesthetic agents Able to attend follow up appointments Exclusion Criteria: Allergy to regional anesthetic Age <18 or >45 years Pregnant females History of neuropathic pain Radiographic signs of osteoarthritis (Tönnis grade 2) Unable to speak/understand English Currently imprisoned Unwilling/unable to provide consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: regional anesthesia bupivacaine<br>regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy | Drug: regional anesthesia bupivacaine<br>* a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy<br>* Other names: Marcaine;|
| Placebo Comparator: regional anesthesia placebo<br>subcutaneous injection procedure placebo (0.9% sodium chloride in water) | Drug: regional anesthesia placebo<br>* subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water)<br>* Other names: Sodium Chloride Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |