Femoroacetabular Impingement
Conditions
Brief summary
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
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).
Interventions
DRUGregional anesthesia bupivacaine
a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy
DRUGregional anesthesia placebo
subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water)
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject log to record number of pain pills taken by subject for 7 days | 7 days | A log that is used by the subject to record how many oral pain medications they take for 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip score | 6 weeks | Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits. |
| Visual analog pain scale | 6 weeks | Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits. |
| iHOT-12 (international hip outcome tool) | 6 weeks | Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits. |
| HOOS (hip disability and osteoarthritis outcome score) | 6 weeks | Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits. |
| Record of Pain Medication given in PACU | immediately post-op (while in PACU, on average 1-4 hours total) | Record narcotic requirements in PACU |
| Reported Falls Post-op | Time inpatient, on average 12-48 hours | — |
| Unplanned admissions and/or readmissions | 6 weeks | number of unplanned admissions/readmission |
| Days until starting rehabilitation | immediately post-op, on average 24 hours - 2 weeks | — |
| Patient satisfaction | 6 weeks | — |
| Duration of time in PACU | immediately post-op, on average between 1-4 hours | — |
Countries
United States
Outcome results
None listed